JP2008545477A - Blood irradiation system device - Google Patents

Abstract

Embodiments of the present application relate to an apparatus, system, and method for irradiating fluid (blood, etc.) using ultraviolet rays, and corresponding related components, systems, and methods. In some embodiments of the present invention, an ultraviolet blood irradiation (UBI) system is provided that provides a defined emission wavelength and irradiates a defined blood volume with an ultraviolet UV light source that has a detrimental effect on viruses and / or bacteria. An exposure chamber, a conduit connecting the UV light source and the exposure chamber, a pump for circulating blood between the first position and the second position, and a time quantification of blood in the room supplied between the UV light source and the exposure chamber A shutter assembly may be provided that provides illumination.

Description

(Priority claim and related applications)
This application is priority to US Provisional Patent Section 119 (e) over US Provisional Patent Application No. 60 / 685,471 (filed May 27, 2005, entitled "Blood Irradiation Device"). The application of which is hereby incorporated by reference in its entirety.

  This application is a continuation-in-part of US Patent Application No. 11 / 285,959 (filed on November 22, 2005) belonging to Petrie, US Provisional Patent Application No. 60 / 630,503 (2004) Claims the benefit of priority under US Patent Section 119 (e) for US Patent Application No. 60 / 638,286 (filed December 21, 2004) and US Provisional Patent Application No. 60 / 638,286. Is. This application is related to US Pat. No. 6,312,593 belonging to Petrie. Each of the foregoing disclosures is incorporated herein by reference in its entirety.

(Field of Invention)
Embodiments of the present invention relate to an apparatus, system and method for irradiating fluid (blood, etc.) with ultraviolet light, and corresponding components, systems and methods corresponding thereto.

  It has been recognized and understood for many years that certain wavelengths of ultraviolet light are capable of destroying certain biological and chemical structures. The sun and many active celestial bodies normally emit a variety of UV light, but some of the Earth's atmosphere prevents its destructive energy forms from reaching the surface.

  In the past century, scientists and healthcare workers have attempted to use UV light in the treatment of illnesses. One such experiment is the development of a basic device in the 1930s that was designed to expose human blood to UV lamps to kill viruses and bacteria. Although the specialty device was successful from a medical standpoint for patients undergoing treatment, it was unsuccessful electrically and mechanically in several factors. First, it was difficult to operate the UV lamp. In other words, it was a main handling problem to let the light of the lamp hit. There were a number of interactive controls that required certain readjustments to continue to operate the device properly. Moreover, the lifetime of the lamp was very short before it was able to shine or generate the UV wavelengths needed for treatment. There was also the problem of continuous general maintenance of the water cooling process and belt drive sequence included in the structure. Furthermore, the control of blood flow by the system required constant adjustment and monitoring by a skilled operator. Blood collection was also difficult due to the design of the device. Specifically, blood was collected using gravity and stored in an open beaker. Thereafter, the beaker was moved to the upper position of the apparatus and discharged through the pump into the exposure chamber.

  Such a situation was rare even if all system components worked properly and a positive therapeutic treatment was obtained. Furthermore, even if mechanical, electrical, or lamp problems occur during the clinical procedure, the system did not suspend the operation with a visual or audible display to notify the operator or automatic failsafe.

  Accordingly, embodiments of the present invention are provided to solve the problems of prior art systems and devices for blood irradiation. Preferred embodiments of the present invention utilize the same basic principles for irradiating blood, but such embodiments provide systems and processes that are dramatically improved. In some embodiments, the system automatically controls and monitors the blood irradiation process. Furthermore, in an embodiment of the present invention, clinical parameters that ensure a safe and therapeutic medical procedure may be set.

  In certain embodiments, the present invention provides a blood irradiation exposure chamber in a blood irradiation system having an ultraviolet UV light source, a connector connecting the UV light source and the exposure chamber, a pump for circulating blood through the exposure chamber, and a UV light source and exposure. A shutter assembly for time-quantitative irradiation of exposed room blood supplied between the chambers is provided. The exposure chamber includes a housing with an inlet conduit and an outlet conduit, a UV filter lens configured to be secured within the housing, a gasket secured within the housing and configured to be substantially adjacent to the UV filter lens. . The gasket includes an opening configured to communicate with the inlet and outlet conduits of the housing. The gasket includes an insert configured to form an exposed area. Further, the exposed area is configured to communicate with the gasket opening. The inlet conduit and outlet, the opening, and the exposure area are configured to form a channel that allows blood to flow into and out of the exposure chamber.

  In an alternative embodiment, the present invention provides a blood irradiation exposure chamber in a blood irradiation system having an ultraviolet UV light source, a connector connecting the UV light source and the exposure chamber, a pump for circulating blood from the exposure chamber, and a UV light source. A shutter assembly is provided for timed quantitative irradiation of blood in the exposure chamber supplied between the exposure chambers. The exposure chamber is a housing with a conduit, another housing with another conduit (the housing is configured to be coupled to the other housing), fixed between the housing and the other housing A gasket with an opening configured to be parallel to the conduit and the another conduit, a filter lens configured to be secured between the housing and the gasket, and the another housing Another filter lens configured to be fixed between the gaskets, and an insertion unit separate from the insertion unit configured to be fixed in the gasket (the insertion unit forms an exposed area in the gasket) Prepare. The conduits, openings and exposed areas that form the channels are configured to allow blood to flow into and out of the exposure chamber.

  In another alternative embodiment, the present invention relates to a microchannel assembly for flowing blood into and out of a blood irradiation exposure chamber in a blood irradiation system having an ultraviolet UV light source, a connector connecting the UV light source and the exposure chamber, from the exposure chamber. A pump for circulating blood, and a shutter assembly for timed constant irradiation of blood in the exposure chamber supplied between the UV light source and the exposure chamber. The microchannel is a conduit configured to be secured to the exposure chamber housing, an opening in the exposure chamber gasket configured to communicate with the conduit, an exposure in the gasket configured to communicate with the opening. A region, another opening in the gasket configured to communicate with the exposed region, and another conduit secured within the housing and configured to communicate with the other opening.

  The foregoing and other embodiments, features, advantages, and objects of the present invention will become more apparent with reference to the following detailed description and accompanying drawings, a brief description of which is set forth below.

  1-17 illustrate some of the embodiments of the present invention. For this purpose, part of the figure includes an ultraviolet blood irradiation (UBI) system (“blood modulator” with mechanical and electrical components specifically arranged to provide clear UV irradiation to the patient's blood. Is also called). According to some embodiments of the present invention, such mechanical and electrical components may comprise an ultraviolet (UV) lamp, a fluid pump, an exposure chamber and control logic means. Such embodiments may also include various sensory items and other operational steps for monitoring and performing irradiation.

  FIG. 1 illustrates one embodiment of the present invention relating to a UBI system for blood (and other fluid) irradiation. As shown in the figure, this system is stored in the simple cabinet 2 and may be provided as a tabletop unit or provided with a structure (such as a cart) with wheels so that the cabinet / system can be easily transported. . A cabinet / housing 8 that houses the blood exposure chamber of the pump 4, the control panel 6, and the administration set (shown below) may be installed in the cabinet.

  The control panel may include control units such as a main power switch 10, a UV lamp switch 12 (preferably a key switch), a pump switch 14, and the like. Each switch may also include one or more corresponding LED lights 18 that indicate the state of the associated mechanism (eg, main power “on / off”). For example, the main power switch may include a red LED that lights when the switch is in the “on” position. Similarly, the UV lamp switch preferably comprises a series of associated LEDs that indicate a “warm-up” state (the UV lamp is warming up to an operational state). For example, during a short period of time (about 30-120 seconds, preferably about 90 seconds, etc.), the red LED will first turn on the lamp (indicating that the lamp is not ready to irradiate blood). Turns on and then turns off when the lamp reaches an operating state, at which point the green LED may light up to indicate that the UV lamp is ready to irradiate blood (or the red LED turns green) May change). In order to prolong the life of the UV lamp, it is preferable that the lamp is turned on and off at a minimum. Therefore, if multiple patients need to be treated, the UV lamp is preferably left “on” during that time (eg, it remains “on” between each blood exposure).

  The UV lamp preferably provides a specific emission wavelength that is known to have a clinical effect of destroying or substantially destroying viruses and / or bacteria. Such wavelengths are for example 200-200 for the treatment of human immunodeficiency virus (HIV-1, HIV-2), acquired immunodeficiency syndrome (AIDS) in human and animal whole blood, blood products and processed blood components. It may be 400 nm. The UV lamp may be placed in a glass tube to stabilize and maintain an appropriate operating temperature and to eliminate contact with foreign objects. In one embodiment of the invention, the UV lamp comprises a 210 watt medium pressure mercury lamp with a 2.0 "arc, a total length of about 8.5 inches, and a width of about 1.0 inch, but with different wattage, length, width, Other types of arc UV lamps may be used, and those skilled in the art will appreciate that the bulbs can be modified to other types, as shown in Figure 2 for certain types / sizes that may be used in embodiments of the present invention. Fig. 3 shows a side view of a UV lamp and Fig. 3 shows the lamp relative spectroscopy and energy output.

  The pump 4 is used to allow blood to flow into and out of the exposure chamber, preferably in both directions, at a defined flow rate. In the preferred embodiment, the pump comprises a peristaltic pump, although other types of pumps may be used. Pump flow rate is variable depending on various variables such as UV lamp intensity, exposure chamber design and / or volume, size / diameter of tube / conduit (such as PVC or silicone tube) carrying blood between pump and / or exposure chamber You may let them. It is preferable to set the flow rate of the fluid in the pump to a predetermined measurement amount, but in some embodiments of the present invention, a controller that adjusts the flow rate to various settings may be provided. Normally, the specified set flow rate may be checked periodically to ensure proper operation of the system. Such an inspection may be performed by a visual flow indicator (such as a flow meter). A commercially available flow rate sensor may be provided to monitor the flow rate and stop the system when a specified amount (± 5% of the optimum flow rate) or more is reached. Such monitoring may be performed by an electrical / computer control system (etc.).

  FIG. 1 also illustrates a UBI system with a connected dosing set 16. According to some embodiments of the invention, the administration set is a single use disposable system. This prevents the blood of one patient from mixing with the blood of another patient and allows the system to be operated inexpensively and effectively. As shown, the patient's blood is stored in a storage container 18 (IV bottle / bag). A portion of the tube of the dosing set is in the peristaltic pump so that the pump can work on the tube and generate pump pressure in one direction, preferably in both directions, depending on the flow of blood into the storage container. Detained.

  As shown in FIG. 4, in some preferred embodiments of the system, the dosing set includes an injection needle 20 for insertion into a patient and collection and infusion of blood, with the injection needle connected directly to a three-way stopcock 22. Alternatively, one long PVC / silicon tube 24 may be connected to the stopcock and needle. The stopcock is connected to the venous tube by a PVC tube 28. The three-way stopcock is connected to a patient needle and has a port for transporting fluid to the patient (patient port), another port 30 for a syringe (syringe port), and a third to allow fluid to flow into and out of the system. May be provided. A roller clamp 32 (or other clamp) may be provided along the PVC tube connecting the stopcock to the infusion tube to stop blood flow into the patient. The infusion tube may then be connected to a venous blood storage container 34 with a soft surface by a single PVC tube 36 and connected to one of the exposure chambers 38 (see FIG. 5) by a PVC tube 40.

  A single silicon tube 42 (which may be used in combination with a peristaltic pump) goes from the other side of the exposure chamber to a blood spike 44 for insertion into an IV bottle (vacuum bottle such as McGaw's Vac Bottle 500 ml). Connected. Silicone tubes may be used along the entire length of the blood spike from the UV exposure chamber, but PVC tubes may be used as well or in combination.

  A venous blood storage bag 34 with a soft surface is shown in FIGS. In some embodiments of the present invention, a soft surface bag, preferably a plastic tube 46 with sufficient rigidity so that it does not collapse when the tube is depressurized, is provided in the bag. The tube 46 preferably includes an opening 48 (or a plurality of openings) at the base position of the bag 34 near the first opening 50 of the tube to carry liquid through the tube. A second opening 52 located at the opposite end of the tube may also be provided to carry liquid through the tube. When the bag is depressurized (low pressure), the fluid flows through the tube 46 in the low pressure direction when the bag surface (including a plurality of portions) falls over the opening 48. That is, when the opening 52 is depressurized, the fluid flows from the opening 50 to the opening 52, and when the opening 50 is depressurized, the fluid flows in the opposite direction. The bag also functions as a storage container (filled with fluid) of fluid (blood, etc.) to be transported by standard pressure (such as atmospheric pressure) or positive pressure applied to the bag. Accordingly, the opening 48 acts as a valve depending on the positive or negative pressure applied to the bag in combination with the bag.

  Other embodiments of the venous blood storage bag may include a rigid bag with a tube having a valve provided in the tube base portion. In contrast to the above-described embodiment, in this embodiment, the opening of the tube base does not require a bag surface (including a plurality) covering the hole when a negative pressure is applied to the tube. Instead, a mechanical valve adjacent to the opening in the tube opens and closes the opening in response to positive pressure (open position) or negative pressure (closed position). Such a mechanical valve may simply consist of a plastic “flap” (such as a plastic sheet) attached to the opening or near the opening side, and in the case of negative pressure, the flap will open the opening. Cover / substantial seal and, in the case of positive pressure, fluid / blood is passed through the opening for storage in the bag (temporarily etc.). Further, for example, other types of valves such as a ball valve may be used.

  Thus, the bag functions as a conduit when decompressed when collecting the patient's blood, and the therapeutic flow and return to the patient when blood (treated or untreated) is reinfused into the patient. It functions as a storage container for collecting the differential blood volume from the diversion. Thus, in some embodiments of the present invention, the design of the bag xx minimizes hemolysis in either direction of blood flow and allows a large amount of return blood to be collected. For the convenience of the operator, the bag is provided with a volume indication on one or both sides of the bag side and may be used in conjunction with whole blood or blood product treatment.

  The infusion tube 26 of the administration set may be used to adjust the flow rate to be depressurized and the needle diameter during blood collection, or to adjust the volume of reinjected blood to the patient. The reduced pressure may be ensured by the reduced pressure present in the reduced pressure bottle (transferred to the bag 34 when the blood spike 44 is inserted into the reduced pressure bottle) or other methods (such as a pump or syringe). In some embodiments of the present invention, the standard blood flow rate is about 25-30 ml per minute and the standard return flow is preferably about 10-20 ml per minute. In general, the amount of blood collected by a patient may vary from patient to patient.

  Typically, the reinfusion flow rate is generally limited to the flow rates described above (or similar flow rates disclosed in the prior art and / or flow rates known to those skilled in the art). High reinfusion flow rates can cause considerable discomfort. The blood reinfusion volume may be adjusted by the operator / doctor / nurse using a drip tube (etc.) and a visual indication of the IV valve. In many cases, it is preferred that the irradiation step be completed before returning all blood to the patient. For this purpose, the storage bag allows the patient to be removed from the UBI system and rested at another location while the remainder of the patient's irradiated blood is returned to the patient. This frees up the UBI system and allows additional treatment to other patients. In some embodiments, if properly managed, treatment for one patient may be performed about every 12 minutes. The time may be shortened or extended depending on the flow rate, the blood collection amount, and the irradiation amount (tube diameter used, difference in dose, etc.).

  The reduced pressure may be released into the atmosphere before blood is returned to the patient after irradiation. Stopcocks or other methods known to those skilled in the art may be used. Therefore, by eliminating pressure reduction, the soft surface of the storage bag 34 is relaxed, and the return blood can be accumulated / stored in the bag 34 (functioning as a storage container).

  Also, the exposure chamber 38 of one embodiment described in FIG. 5 may be considered as part of an administration set (also preferably a single disposable unit) or as another component thereof. The exposure chamber may include two openings to allow blood to flow from one of the devices to the other, preferably allowing the exposure chamber to be substantially filled with blood. The exposure chamber preferably comprises one or more protrusions and creates turbulence in the blood flow. Due to the turbulence of the blood flow, it can be completely irradiated by the UV light source. Also, the exposure chamber may preferably be provided with a UV transparent quartz cover of about 1400-4000 Angstroms or about 140-400 nm on one side (such as a UV irradiated surface). The exposure chamber is preferably designed to be disposable and easily installed and removed from the system. An example of such an exposure chamber is US Pat. No. 6,312,593 by Petrie, which is incorporated herein by reference in its entirety.

  FIG. 9 is an exploded perspective view of a UBI system according to some embodiments of the present invention. As illustrated, the cabinet xx may include a cabinet base portion 54, a front bumper 56, an intermediate winding portion 58, and a cover 60. The pump 4 and the control panel 6 may also be referred to from this figure, as well as the exposure chamber housing assembly that houses the exposure chamber 38. The exposure chamber housing may include a chamber table 64, a shutter assembly 62, a chamber bracket 66, and a front panel 68.

  FIG. 10 is an exploded perspective view of components stored in the central winding portion of the UBI system according to some embodiments of the present invention. Reference is also made to FIGS. As shown, a shutter assembly 76 including a UV lamp housing 72 (which stores a UV lamp), a chopper wheel assembly 74, and a front panel 78 may be stored in the intermediate winding portion. Preferably, the UV lamp housing comprises an air-cooled plenum or a part of the air-cooled plenum installed in the central winding part. The plenum may be used or aided to maintain the proper temperature of the local part of the UV lamp so that the UV lamp does not overheat (resulting in a system shutdown). Such a plenum may include ducts 80 and 82 and may be connected to the duct ends / baffle plates 84a, b, respectively.

  Between each air guide plate (or at least one of the air guide plates) and each duct, blower units 86a, b (fans are placed in other areas of the intermediate winding section or other parts of the cabinet / UBI system) May be provided). Each duct may include a deflector plate 88 to deflect all or part of the airflow in a defined direction and / or split the airflow. As shown in the figure, the deflecting plate may be disposed in the center of the opening at the end of the duct connected to the UV lamp housing, and the lamp and the chopper wheel mechanism may each receive part of the airflow. The filters 90a, b are preferably arranged at one or both ends of the air guide plate (depending on the direction of the airflow). Preferably, the filter is replaceable and conveniently located in a part of the cabinet that is easily reachable (to allow easy replacement).

  The airflow through the UV lamp assembly may be unidirectional such that it is pushed by the fan 86a, flows into the baffle plate 84a, and exits the baffle plate 84b (drawn by the fan 86b). Alternatively, airflow may flow from both ducts into the UV lamp housing. That is, both the fan 86a and the fan 86b draw air into each wind guide plate, and each duct guides the air to the UV lamp housing. In the latter case, a vent hole may be provided so that air is discharged from at least one of the UBI system (entire), the lamp housing, and the intermediate winding portion.

  FIG. 11A is an exploded view of a shutter assembly according to some embodiments of the present invention that controls whether UV radiation is provided to the exposure chamber. The shutter assembly includes a filter (s) 92 that removes certain wavelengths of the electromagnetic spectrum and is stored by filter brackets 94 and 96 (or other structures such as clip 98 and fastener 100). Also good. The shutter assembly may also include a chamber mounting plate 102, a shutter plate assembly 104, a chamber bracket 106, a chamber fixing assembly 107 (having springs 108a and b), and a cell release cam 110. The chamber bracket is slidably connected to the chamber fixing assembly, and the upper portions of the springs 108a and 108b are attached to the lower portion of the chamber bracket, and the lower portion of the spring is attached to the lower portion of the chamber fixing assembly.

  The chamber mounting plate has an opening 112 and allows UV radiation to pass through. The shutter plate assembly may have a corresponding opening 114 to allow the radiation irradiated from the chamber mounting plate opening 112 to pass through. The shutter plate assembly may also include an elongated radial arc 116 slidably connected to the top of the chamber bracket 106.

  The shutter plate assembly may also include a cam lever 118 that allows the operator to manually open and close the shutter as the exposure chamber is inserted or removed. It will be appreciated by those skilled in the art that such manual operation can be substituted for a servo mechanism or other mechanical or electromechanical device that opens and closes the shutter by operating parameters and / or a switch on the control panel (or adjacent to the shutter assembly). Will be understood. Inserting the exposure chamber into the chamber storage window pushes down the exposure chamber (such as by an operator) and releases the fixed cam. The cam lever may then be moved from right to left to lock the exposure chamber in place, and in some embodiments, the exposure window is released simultaneously.

In some embodiments, movement of the cam lever 118 causes the protrusion 116a to contact the top of the exposure chamber inserted into the chamber bracket and overlap along the outer diameter of the exposure chamber while pushing down the exposure chamber. That is, this causes the lower part of the exposure chamber to activate the cell release cam 110. Push down on top of chamber fixation assembly. As a result, the projection 116a is raised to the maximum point at the 12 o'clock position in conjunction with the chamber fixing assembly (the spring is extended). This occurs when the lever is rotated in one direction ("open hole" position). To release the exposure chamber, the lever is moved in the opposite direction so that the protrusion 116a does not engage the exposure chamber and the chamber bracket 106 moves downward.

  Thus, when lever 118 is in the “open” position (see FIG. 11C: lever 118 is rotated to the right position), it is positioned at the appropriate location for exposure chamber UV irradiation to prevent radiation leakage from the front of the UBI system. . If the lever 118 is in the “closed” position (see FIG. 11B: the lever 118 is rotated to the left position), the exposure chamber may be removed from the UBI system. Accordingly, movement of the lever 118 in one direction or another direction acts on the open / close position. In other words, the opening 114 of the shutter plate assembly moves to a position corresponding to the opening 112 of the chamber mounting plate or a position where the opening 114 of the shutter plate assembly does not overlap with the opening 112 of the chamber mounting plate ( Of course, other “partially open” positions are possible depending on the UBI specific use).

  The central portion of the shutter plate assembly is preferably made of polytetrafluoroethylene or Teflon®, but may be other structures of the shutter assembly exposed to UV. Polytetrafluoroethylene is a preferred material because it can withstand repeated exposure to UV that has a long-term deleterious effect on many materials.

  FIG. 12 shows an exploded perspective view of the UV lamp housing 72. As shown, the lamp housing includes an internal light port 120, a chopper assembly plate 122 (having an opening 124 through which the chopper wheel 126 passes), a lamp bracket 128, a lamp 130, and springs 132a, b. A plurality of fasteners 134 may be used to assemble one or more components. If the air plenum (see above) is unable to maintain cooling of the UV lamp, one or more temperature sensing current circuit breakers 136 (such as one or more thermistors) may be provided to shut off the UV lamp (but the air plenum Is preferably maintained in an operable state). Such a thermistor is placed in series with a portion of the air plenum outer surface facing the UV lamp so that when the plenum surface temperature reaches 50 ° C (etc.), the lamp is shut off and prevented from being restarted. Also good. In other exemplary embodiments, the temperature can reach up to 90 ° C. Such a series of double wiring thermistor designs may be used as an extra safety system design for additional protection. This feature increases the lifetime, increases the number of turn-on irradiations, and allows for stable and repeatable UV wavelength radiation from the UV lamp.

  FIG. 14 is a front view of a chopper wheel device according to some embodiments of the present invention, and FIG. 15 is a top view. The chopper wheel device has a “shutter” effect on the radiation. As shown, the chopper wheel device may include a motor 138, a mounting bracket / plate 140, and a “bow tie” disc 142. FIG. 10 shows a diagram in which the shutter effect of UV radiation is generated from the UV lamp in response to the rotation of the bow-tie disk. That is, a part of the bow-tie disk lacks a material that allows radiation to pass through the opening 114, and the remaining part blocks radiation. Thus, the chopper wheel mechanism provides a timed exposure of blood in the exposure chamber. Specifically, the chopper wheel provides alternative “open” and “closed” positions for opening between the UV lamp and the exposure chamber. The timing of the chopper wheel / appliance device may be determined using the specific synchronous motor and gear drive selected in this application. Thus, due to the specifications of such components, the timing is very accurate and usually only changes due to major failures. In some embodiments, the chopper device is a belt driven chopper device.

  In some embodiments of the present invention, the chopper wheel assembly preferably stops the chopper wheel in a position that substantially prevents radiation, i.e., the chopper wheel rigid portion includes a stop device that closes the opening 114. Prepare. This feature serves as an additional safety feature and prevents radiation from being transmitted to the exposure chamber when the system is shut down. Thus, during such a system stop, the chopper wheel rotation automatically stops in place so that no open area of the chopper wheel overlaps the lamp housing opening 114 and / or opening 73. .

  The UBI system according to some embodiments of the present invention is preferably designed to provide fail-safe electrical and mechanical operation to ensure that blood components are not damaged or the patient is not at risk. . This may be done by controlling and monitoring various system parameters (such as those described above) necessary to ensure a safe and therapeutically effective medical procedure. Devices may be classified into five functional states according to control logic (such as electronic hardware and / or software). Three of them may be drivable, alert, and fail-safe. The transition from one state to another may be based on sensory information obtained from various sensors that monitor various system components.

  FIG. 16 is a block diagram of the above-described system and its components and additional components for controlling and / or monitoring such components and the entire UBI system. In response, the UV lamp 144 emits a specific wavelength that enters the exposure chamber 150 after passing through the aperture of the chopper wheel assembly 146 and shutter 148. To achieve this, several conditions may be met, preferably according to the system functions described in connection with the components of FIG.

State 1: A state in which one or more (preferably all) of the following states are generated.
-Chamber 150 is not inserted into the system.
The shutter 152 is closed.
-The chopper wheel 146 is off.
The UV lamp power control unit 154 is turned on.
The pump power control unit 156 is turned on.

State 2: A state in which one or more (preferably all) of the following states are generated.
-Chamber 150 is inserted into the system.
The shutter 152 is closed.
-The chopper wheel 146 is off.
The UV lamp power control unit 154 is turned on.
The pump power control unit 156 is turned on.

State 3: A state in which one or more (preferably all) of the following states have occurred.
-Chamber 150 is inserted into the system.
The shutter 152 is open.
-The chopper wheel 146 is on.
The UV lamp power control unit 154 is turned on.
The pump power control unit 156 is turned on.

State 4: A state in which one or more (preferably all) of the following states have occurred.
-Chamber 150 is inserted into the system.
The shutter 152 is open and the chopper 146 is off.
The UV lamp power control unit 154 is turned on.
The pump power control unit 156 is turned on.
• Pump on / off switch 168 is off or flow sensor 166 indicates “zero flow.

Fail-safe state: A state in which one or more (preferably all) of the following states occur.
The chamber 150 is inserted in the present invention.
The shutter 152 is open.
-The chopper 146 is in an unknown state.
The UV lamp power control unit 154 is not turned on.
The pump power control unit 156 is not turned on.

The following signal sensation information (see figure xx) is preferably used by the control logic to determine the appropriate operating state.
Signal monitoring Figure xx item 1-shutter fully open sensor 158
2-Shutter fully closed sensor 160
3-Chopper first position sensor 162
4-Chopper second position sensor 164
5-flow rate 166
6-pump switch 168
7-lamp switch 170
8-120V AC lamp thermal breaker 172
9-room position sensor 174
Based on one or more statuses of such signals, status information of the associated system may be provided to an operator and / or a monitoring system (such as a computer). This status indicator using auditory and visual means may be classified into two states. (1) a warning mode informing the operator of an operator's procedural error; and (2) severely visual and / or audibly alarming a serious failure of the hardware device (and / or software) and controlling the device by control logic 175. This is an alarm mode that may cause a fail-safe state.

好適な本発明の実施形態において、制御論理１７５によって、（好ましくは）常に、本発明の運転可能状態を決定してもよい。例えば、ＡＣスイッチ１８６を作動し、本機器の電源がオンになると、１２０Ｖ ＡＣ１８７（など）が、機器内で、電源１８８、操作電子機器、およびランプオン／オフスイッチ１７０に回送される。従って、制御論理１７５は、好ましくは、運転可能状態を状態１に強制する。

In a preferred embodiment of the present invention, the control logic 175 may (preferably) always determine the ready state of the present invention. For example, when the AC switch 186 is activated and the power of the device is turned on, 120V AC 187 (etc.) is routed to the power source 188, the operating electronics, and the lamp on / off switch 170 within the device. Accordingly, the control logic 175 preferably forces the ready state to state 1.

  According to some embodiments of the present invention, chamber 150 is first inserted into the system as part of a normal medical procedure in which the patient's blood is UV irradiated. As shown in FIG. 17, the transition from the state 1 to the state 2 is started by inserting the exposure chamber 150 into the system. The room sensor 174 confirms the proper insertion position by sending a signal 192 to the control logic 175 and then transitions to state 2. When chamber 150 is removed from the system (chamber housing), it immediately returns to state 1.

  In order to continue the blood irradiation process, the opening (shutter mechanism) 152 is opened by the manual operation of the equipment operator. Accordingly, the UV lamp 151 is preferably irradiated with the contents in the chamber 150. The transition from the state 2 to the state 3 may be started by the main operation of opening the opening 152. Shutter sensor (s) 194 may determine whether shutter 152 is fully closed or fully open via signals 158 and 160. If the sensor 160 that senses the fully closed state of the opening indicates that the opening is not fully closed (the opening is partially open), the control logic 175 forces the device to state 3. If the sensor 158 that senses that the aperture is fully open does not indicate the fully open state, a simple warning (# 3) may be issued to inform the operator of the system that the aperture is partially open. By fully closing aperture 152, control logic 175 may preferably force the device back to state 2. If the chamber 150 is not properly inserted into the system at the start of the process, the safety features of the aperture mechanism 152 prevent the aperture from being opened (even if partially), so that from state 2 It is important to note that the transition to 3 is preferably prevented.

  As the medical procedure in state 3 continues, blood is preferably pushed into chamber 150 by pump 196. To determine if this condition has occurred, the sensor 168 monitors the IV tube for flow indication and sets the switch to the “on” or “off” position or determines the state of the pump switch 168 output. Is done. If any of these conditions determine that blood is not moving into the chamber, a “zero flow” condition is preferably displayed. It should be noted that such a “zero flow” state is preferably forced into state 4 by control logic 175. If the pump power is turned off and then on again (such as pump switch 168 from “off” to “on”), the control logic 175 preferably returns the system to state 3. Closure of the aperture 152 preferably causes the system to return to state 2 by the control logic 175.

  When in state 3, the optical aperture blocking chopper wheel 146 may be actuated. When activated, the chopper wheel preferably rotates at a specific RPM (revolutions per minute). Rotation causes periodic “on” and “off” timing features in chamber 150 illumination. Wheel movement may be continuously measured by sensor 148, preferably monitoring two specific locations along the outer circumference of the wheel. In particular, sensor 148 may forward position signals 162 and 164 to control logic 175. The timing of this wheel rotation is preferably measured to ensure an appropriate exposure time for blood flow into the chamber 150. If the chopper wheel 146 stops moving, the control logic 175 may receive signals 162 and / or 164 from the sensor 148 indicating such a failure. As a result, control logic 175 may issue a warning (# 4) to inform the operator of a hardware failure, and preferably turns off both lamp power control unit 154 and pump power control unit 156. If the sensor 148 fails, the movement of the chopper wheel 146 cannot be determined. Even in the case of such a failure, the control logic 175 may issue an alarm (# 4), and both the lamp power control unit 154 and the pump power control unit 156 may be turned off. These two fault conditions preferably force the device to fail-safe by control logic 175. In the preferred embodiment, one way to clear this condition is to turn off the AC switch 186, remove the device power, and repair the failed item.

  Also, in some preferred embodiments, as an additional safety feature, control logic 2 ensures that the chopper wheel 146 waits in a particular physical direction. That is, when stopped at the stop position, the optical opening of the lamp 144 and the chamber 150 is blocked. Such a stop direction may be forced whenever the device is in state 1, 2, or 4 (etc.). This feature provides secondary assistance to the aperture 152 and does not use the designated exposure chamber 37 (and so on) and may cause accidental UVs to the operator and / or patient if the mechanism is improperly opened. Protect from exposure.

  In some embodiments of the invention, in all operating conditions, control logic 175 monitors the occurrence of two specific faults in the system. First, the control logic monitors the system's internal system timing clock 198 for failures. Such a failure may cause control logic 175 to initiate an immediate transition of the device to a failsafe state. In particular, the control logic 175 may activate an alarm (# 5) and turn off both the lamp power controller 154 and the pump power controller 156. The second fault is overheating and the thermal circuit breaker 172 is “opened” thereby removing AC power from the lamp power sensor 200 and lamp power 155. In the case of such a failure, the device may not be able to illuminate the lamp 144, and as a result, the power supply may be removed and repaired. The alarm (# 6) state can inform the operator of this state.

Thus, the above-described embodiments can safely and effectively irradiate blood (and / or other fluids). Such embodiments may be used to irradiate blood according to the following exemplary professionals and calls. For example, the patient receives one or more sessions over a period of 3 weeks, preferably 5 ultraviolet blood irradiation treatments.
Treatment # 1 Start Treatment # 2 Within 48 hours of previous treatment # 3 Within 72 hours of previous treatment # 4 Within 5 days of previous treatment # 5 Within 5 days of previous treatment

治療は、標準２０径の点滴カテーテルを患者の血管に挿入し、以下の化学式： Ａ＝ＫＷ（Ｋは定数（１．５ｃｃ）、Ｗは患者のポンド体重）に従って、体重１ポンドにつき血液１．５ｃｃを採取することによって行ってもよい。好ましくは、総採取血液量は、２５０ｍｌを越えないものとする。

Treatment is performed by inserting a standard 20-diameter infusion catheter into a patient's blood vessel, and 1 blood per pound of body weight according to the following formula: A = KW (K is a constant (1.5 cc), W is the patient's pound weight) It may be performed by collecting 5 cc. Preferably, the total collected blood volume does not exceed 250 ml.

  The blood may be collected in a vacuum container prepared with 3000-5000 units of heparin sodium. The container may be carefully inverted so that the heparin and blood are mixed and then hung on an IV pole associated with the UBI system. The blood then circulates through the exposure chamber so that at a rate of about 30 ml / min, the blood is UV irradiated (such as about 200 nm to about 400 nm UVC) and returned to the patient.

  The irradiated blood may then be returned to the patient at the fastest infusion rate allowed (per standard dosing set). Normal treatment time is about 20 minutes.

  Other embodiments of the present invention may comprise a system for diagnostic applications with and without the use of drugs. For example, a defined treatment using one or another of the system / device embodiments described above simulates an immune system that initially looks for blood infectious agents and inflammation. A blood test at a specified time may be exposed at a later date and contribute to the diagnostic process. Such treatment may also exacerbate mild inflammatory reactions and undetectable infections, but can be detected by imaging devices, blood tests and patient feedback.

  FIGS. 18-26 show an exemplary embodiment of an exposure chamber 1800. FIG. 18 is an exploded perspective view of the exposure chamber 1800. Chamber 1800 includes a first housing 1810a, a second housing 1810b, a gasket 1815, a first UV filter lens 1820, a second UV filter lens 1825, a first insert 1840, and a second insert 1845. Prepare. Housings 1810a and 1810b are configured to couple and form an exposure chamber 1800. Gasket 1815, filters 1820, 1825, and inserts 1840, 1845 are configured to fit within and between first housing 1810a and second housing 1810b. The first insertion portion 1840 and the second insertion portion 1845 are configured to be fixed in the gasket 1815. As will be appreciated by those skilled in the art, single or multiple inserts can be configured to be installed within gasket 1815.

  The first housing 1810 a includes a first conduit 1830. The second housing 1810 b includes a second conduit 1835. Conduits 1830 and 1835 serve as ports for blood or components thereof to enter and exit the exposure chamber 1800. In certain embodiments, the first conduit 1830 functions as an inflow port and the second conduit 1835 functions as an outflow port. In certain alternative embodiments, the functions of conduits 1830 and 1835 are reversed.

  Figures 19-22 show the housings 1810a and 1810b in more detail. FIG. 20 shows the first housing 1810a. Since the second housing 1810b is similar to the first housing 1810a, the description of the first housing 1810a is applicable to the second housing 1810b. FIG. 20 is a top view of the outer surface 2030 of the first housing 1810a and a side view of the housing 1810a. The side view of the first housing 1810a is along the arrow lines AA and BB shown in the top view of the first housing 1810a. The housing 1810a has a circular or donut shape with an empty interior 2043. A non-hollow portion 2012 of the housing 1810 a surrounding the empty interior 2043 is surrounded by an inner end 2015 and an outer end 2013. The outer end 2013 has a diameter R1 as shown in FIG. The diameter of the inner end 2015 is smaller than the diameter of the outer end 2013.

  The non-hollow portion 2012 of the housing 1810a includes an opening 2031 (a, b, c, d, e, f). Opening 2031 secures first housing 1810a and second housing 1810b during assembly of exposure chamber 1800. The housing is secured by bolts, screws, fasteners, or any other suitable means. As shown in FIG. 20, the openings 2031 are uniformly spaced at the outer surface 2012. This ensures that the housings 1810a and 1810b are fitted securely and airtight. In particular, each opening 2031 is separated from the other opening 2031 by an angle A1. The opening 2031 is arranged at a distance L1 from the outer end 2013 of the housing 1810a.

  The housing 1810a includes a first conduit 1830. A conduit 1830 projects from the outer end 2013. First conduit 1830 includes a tube 2023 having a hollow interior 2025, an outer tip 2022, and an inner tip 2024. 20, the outer tip 2022 is disposed on the outer side of the first housing 1810a, and the inner tip 2024 has an inner end 2015 at the inner surface 2010 (side view of FIG. 20). Placed on). The first conduit 1830 is fixed to the inner surface 2010 of the housing 1810a.

  Further, the housing 1810a includes a groove portion 2050 as shown in the BB sectional view of FIG. Groove portion 2050 houses second conduit 1835 (also not shown in FIG. 20) of second housing 1810b (not shown in FIG. 20). The second housing 1810b includes a similar groove portion (not shown in FIG. 20) that houses the first conduit 1830. In some embodiments, as shown in section BB of FIG. 20, the groove portion 2050 includes a number of grooves 2051 that accommodate the conduit 1830. In an alternative embodiment, the grooves 2051 on the housings 1810a and 1810b are configured to fit into the conduits 1830 and 1835, respectively, and form a hermetic connection between the two housings 1810a and 1810b.

  FIG. 21 shows the inner surface 2010 of the housing 1810a. FIG. 21 also shows a side view of the housing 1810a, where one side view is a directional cross-sectional view of the housing 1810a along the line CC (named “cross-section CC”), and the other side view is FIG. 10 is a plan side view of the housing 1810a. As shown in FIG. 21, the inner surface 2010 includes an opening 2031 corresponding to the opening 2031 shown in FIG. Opening 2031 passes through housing 1810 a from outer surface 2030 to inner surface 2010. The opening 2031 has a similar structure in the second housing 1810b. The openings in the first and second housings 1810a and 1810b interact to secure the two housings in the chamber 1800 assembly.

  The top view of the inner surface 2010 in FIG. 21 shows that the conduit 1830 and the groove portion 2050 are disposed along the same line on the inner surface 2010 of the housing 1810a. Alternatively, the conduit 1830 and the groove portion 2050 can be located at different locations on the inner surface 2010.

  The inner surface 2010 of the housing 1810 a includes a ledge 2145 and side surfaces 2147 disposed along the outer end 2013. The side surface 2147 is substantially perpendicular to the inner surface 2010 and protrudes from the inner surface 2010. Housing 1810b includes similar ledge 2145 and side 2147 on its inner surface 2010. During assembly of chamber 1800, the ledges and sides in both housings contact each other and form a secure connection between housings 1810a and 1810b. When housings 1810a and 1810b are bolted (or secured together) using opening 2031, ledge 2145 and side 2147 provide additional securing. In certain embodiments, additional securing mechanisms can perform securing of housings 1810a and 1810b to provide additional securing. Such a fixing mechanism can be a snap-type fixing, a friction fit fixing, or any other fixing mechanism suitable for this purpose. The mechanism can be placed anywhere on the housings 1810a and 1810b.

  In addition, the inner surface 2010 of the housing 1810 a includes a ledge 2146 and a side surface 2148 disposed along the inner end 2015. Side surface 2148 is perpendicular to and projects from inner surface 2010 of housing 1810a. Ledge 2146 houses the arrangement of UV filter lens 1820 and gasket 1815 (similar to housing 1810b where ledge 2146 houses the arrangement of UV filter lens 1825 and gasket 1815). In some embodiments, the side surface 2148 has a thickness that is substantially equal to the combined thickness of the UV filter lens 1820 and up to half the thickness of the gasket 1815. The design of ledge 2146 and side surface 2148 in both housings 1810a and 1810b allows for a secure and airtight assembly of chamber 1800.

  The cross-sectional view of section CC in FIG. 21 shows the opening 2171 in the conduit 1830. The size of the opening 2171 is specific to the design of the chamber 1800 and is based on the specification of the system described above in FIGS.

  FIG. 22 shows the gasket 1815 of the exposure chamber 1800. The gasket 1815 includes an outer edge 2212 and an inner edge 2214. Inner edge 2214 includes side surfaces 2216a and 2216b. The side surface 2216 is disposed along the circumference of the inner edge portion 2214. The side surface 2216 forms a groove 2217. The groove 2217 is disposed along the circumference of the inner edge 2214 of the gasket 1815. Groove 2217 is configured to fit inserts 1840 and 1845 and is described below with respect to FIG. The thickness of the groove 2217 allows stable placement of the inserts 1840 and 1845. Inserts 1840 and 1845 can be glued, welded, friction fit, or another way of securing in groove 2217 between sides 2216a and 2216b.

  The gasket 1815 further includes a slit 2218. The slit 2218 is disposed approximately in the middle of the outer edge 2212 and penetrates the groove 2217 from the gasket wall. The slit 2218 is configured to accommodate a protrusion 2512 (not shown in FIG. 22) of the insertion portion 1840 shown below with respect to FIG.

  The gasket 1815 further includes openings 2210a and 2210b. The opening 2210 is arranged at the outer edge 2212 of the gasket 1815 and penetrates the shadow of the gasket into the groove 2217. Thus, the opening 2210 provides a connection between the outer and inner portions of the gasket 1815. Opening 2210 is further configured to coincide with the opening in first and second conduits 1830 and 1835 (not shown in FIG. 22). FIG. 22 further shows that the openings 2210 are positioned so that they are diametrically opposed to each other. As can be appreciated by those skilled in the art, the opening 2210 can be located anywhere on the outer edge 2212 of the gasket, provided that the opening 2210 coincides with the conduits 1830 and 1835.

  FIG. 23 shows a top view and a side view of the gasket 1815. The side view of the gasket 1815 shows the opening 2210a at the outer edge 2212 of the gasket 1815. In certain embodiments, the diameter R2 of the opening 2210a is equal to 0.078 inches. The diameter R3 of the gasket 1815 is equal to 2.3 inches. The width W1 of the outer edge 2212 is equal to 0.15 inches. Other configurations of the gasket 1815 are possible as will be appreciated by those skilled in the art.

  FIG. 24 shows a first UV filter lens 1820. Filter lens 1820 has a diameter R4 and a thickness W2. In some embodiments, R4 is equal to 2.25 inches and W2 is equal to 0.05 inches. The first filter lens 1820 is configured to be positioned between the gasket 1815 and the first housing 1810a, and the second filter lens 1825 is positioned between the gasket 1815 and the second housing 1810b. Consists of. As described above, ledge 2146 and side 2148 of housings 1810a and 1810b secure filter lenses 180 and 1825 to housings 1810a and 1810b, respectively.

  FIG. 25 shows the first insertion portion 1840. Insertion portion 1840 has a thickness W3. In certain embodiments, the thickness W3 is equal to 0.001 inches.

  The insert 1840 has a multi-contour inner surface 2525 and a substantially circular outer surface 2527. The outer surface 2527 includes two circular portions, a 2510a circular portion and 2510b that are distinguished by a protrusion 2512. Circular portion 2510 has a radius R5. In some embodiments, radius R5 is equal to 1.125 inches. Circular portion 2510 and protrusion 2512 are configured to fit within inner edge 2214 of gasket 1815. In particular, the insert 1840 is configured to fit between the side surfaces 2216a and 2216b of the gasket 1815. Also, the protrusion 2512 is configured to fit within the slit 2218 of the gasket 1815. Thereby, the gasket 1815 can fix the insertion portion 1840 to the inner edge portion 2214 thereof. Further, the circular portion 2510 of the insert 1840 is configured to fit within the gasket 1815. In some embodiments, the radius R5 of the circular portion 2510 is substantially equal to the radius of the inner edge 2214 of the gasket 1815.

  Inner surface 2525 includes a central portion 2520 adjacent to two sides 2522a and 2522b. Sides 2522a and 2522b are adjacent to two ends 2524a and 2524b, respectively. Central portion 2520 is circular and has a radius R6. In certain embodiments, R6 is equal to 0.740 inches. The two side portions 2522 are substantially straight and extend from the central portion 2520 toward the end portion 2524. The end 2524 of the insert 1840 is substantially straight so that the inserts 1840 and 1845 are positioned at the end of the insert 1845 when placed in mutually opposite gaskets 1815 as shown in FIG. 26 below. Configured to be parallel.

  The insertion portion 1840 has a width W4 for measuring from the end of the protrusion 2512 to the end 2524. In some embodiments, the width W4 is equal to 1.156 inches. When both inserts 1840 and 1845 are secured to gasket 1815, the insert forms a gap as shown in FIG. A gap is formed between the end 2524, the side portion 2522, and the central portion 2520 of each insertion portion. The gap formed by the ends 2524 of the inserts 1840 and 1845 coincides with the opening 2210 of the gasket 1815.

  When fully assembled, the chamber 1800 forms a microchannel 2610 as shown in FIG. Microchannel 2610 passes through the hollow interior of the gap formed by first and second conduits 1830 and 1835, gasket openings 2210a and 2210b, and 1815 first and second inserts 1840 and 1845 inside the gasket. Including.

  Blood or any other liquid flows through the microchannel 2610 and enters from an entry point that coincides with the outer tip 2022 of the conduit 1830. It then proceeds from the hollow portion of conduit 1830 to its internal tip 2024. Thereafter, the gas continuously flows through the opening 2210a of the gasket 1815. Next, the gap formed by the inserts 1840 and 1845 in the gasket 1815 is entered. When the liquid enters the gap, it spreads on the inner surface 2525 of the insertion portions 1840 and 1845. Then, it continues to flow through the opening 2210b of the gasket 1815. The inner tip 2024 then enters the hollow portion of the conduit 1835. Subsequently, it flows through the hollow portion of conduit 1835 to its exit point 2022. The tips of conduits 1830 and 1835 are coupled to the blood pump and storage device and other components of the blood irradiation system described above with respect to FIGS.

  As blood circulates through microchannel 2610, it is exposed to UV light radiation. Actual exposure occurs in the open area or exposed area 2614. Open region 2614 is formed by inserts 1840 and 1845 as shown in FIG. FIG. 26 shows an exposure chamber 1800 that can be assembled.

  When blood enters the open area 2614, the UV lamp is activated and the blood is exposed to UV light radiation, as described above with respect to FIGS. After exposure, blood exits microchannel 2610 through conduit 1835.

  As described above, the exposure chamber 1800 is configured to be coupled to a pump device and a blood storage container capable of pumping blood in and out through the microchannel channel 2610. In certain embodiments, the width of the microchannel 2610 is equal to 0.010 inches. In an alternative embodiment, microchannel 2610 is 0.005 inches wide. In another alternative embodiment, the width of the microchannel 2610 is in the range of 0.0005 inches and 0.002 inches.

  Microchannel 2610 allows a thin film flow of blood through exposure chamber 1800. As can be appreciated by those skilled in the art, other components such as whole blood or platelets, erythrocyte suppression, factors VIII and IX, or other components can be used for exposure. In certain alternative embodiments, the blood can be diluted with PBS and anticoagulants. The blood can be human blood, animal blood, or any other liquid.

  The gasket member 1815 is manufactured from a biocompatible metal or plastic, or any other suitable material.

  In certain embodiments, the flow rate of blood through the exposure chamber 1800 is about 0.1 to 5 ml per minute. In certain alternative embodiments, the flow rate can be about 1 ml per minute. In another alternative embodiment, the flow rate is in the range of 10 to 15 ml per minute. The flow can be generated by reduced pressure (eg, 10-20 mm Hg) to minimize hemolysis. The flow rate can be increased by raising the lens size and illumination level.

  While certain embodiments of the invention have been described herein, such description is provided by way of example only, and not as a limitation of the invention. Accordingly, as those skilled in the art will appreciate, many other embodiments having some additional or less functionality are within the scope of the invention, some of which are claimed below.

FIG. 1 is a perspective view of a blood irradiation system according to some embodiments of the present invention. FIG. 2 is a side view of an exemplary UV light source (lamp / bulb etc.) according to some embodiments of the present invention. FIG. 3 is a spectral output of a UV light source used in some embodiments of the present invention. FIG. 4 is a schematic side view of a dosing set according to some embodiments of the present invention. FIG. 5 is a perspective view of an exposure chamber according to some embodiments of the present invention. FIG. 6 is a front view of a storage / circulation bag according to some embodiments of the present invention. FIG. 7 is an enlarged portion “A” of the storage / circulation bag described in FIG. 6. FIG. 8 is an enlarged portion “AA” of the storage / circulation bag described in FIG. 7. FIG. 9 is an exploded perspective view of a blood irradiation system according to some embodiments of the present invention. FIG. 10 is an exploded perspective view of the inside of a blood irradiation system according to some embodiments of the present invention. FIG. 11A is an exploded perspective view of a shutter assembly according to some embodiments of the present invention. FIG. 11B is a front view of the shutter assembly in a “closed” position with an exposure chamber therein. FIG. 11C is a front view of the shutter assembly in an “open” position with an exposure chamber therein. FIG. 12 is an exploded perspective view of a UV lamp housing according to some embodiments of the present invention. FIG. 13 is a cross-sectional side view of a blood irradiation system according to some embodiments of the present invention. FIG. 14 is a front view of a chopper wheel assembly according to some embodiments of the present invention. FIG. 15 is a side view of a chopper wheel assembly according to some embodiments of the present invention. FIG. 16 is a block diagram of a blood irradiation system according to some embodiments of the present invention. FIG. 17 is a flowchart of a blood irradiation system according to some embodiments of the present invention. FIG. 18 is an exploded perspective view of a blood exposure chamber according to the present invention. FIG. 19 is an exploded perspective view of two housing portions of the blood exposure chamber described in FIG. 18 of the present invention. 20 is a top view and two cross-sectional side views of the outer surface of the housing portion of the blood exposure chamber described in FIG. 18 of the present invention. FIG. 21 is an inner surface top view and two side views of the housing part of the blood exposure chamber described in FIG. 18 of the present invention. FIG. 22 is a perspective view of the blood exposure chamber gasket according to FIG. 18 of the present invention. 23 is a top view and a side view of the blood exposure chamber gasket according to FIG. 22 of the present invention. 24 is a top view and a side view of the UV filter lens of the blood exposure chamber described in FIG. 18 of the present invention. 25 is a top view and a side view of the insertion part of the blood exposure chamber described in FIG. 18 of the present invention. FIG. 26 is an assembly view of the blood exposure chamber described in FIG. 18 of the present invention.

Claims (34)

An exposure chamber for irradiating blood within the blood irradiation system, the blood irradiation system comprising:
UV light source of ultraviolet rays,
A connector between the UV light source and the exposure chamber;
A pump that pushes blood through the exposure chamber;
A shutter assembly provided between the UV light source and the exposure chamber for timed quantitative irradiation of the blood in the exposure chamber, the exposure chamber comprising:
A housing comprising an inlet conduit and an outlet conduit;
A UV filter lens configured to be secured within the housing;
A gasket secured within the housing and configured to be substantially adjacent to the UV filter lens, the gasket comprising an opening configured to communicate with the inlet conduit and the outlet conduit of the housing And the gasket comprises an insert configured to form an exposed region, the exposed region further configured to communicate with the opening of the gasket, the inlet conduit and the outlet conduit The exposure chamber, wherein the opening and the exposure region are configured to form a channel to allow blood flow from the exposure chamber.   The chamber of claim 1, wherein the gasket comprises another insert and another opening, the other opening being configured to communicate with the outlet conduit.   The insert and the other insert are provided with a multi-contour end and are configured to be secured within the gasket, the multi-contour end being further configured to form the exposed region within the gasket. The chamber of claim 2, wherein the exposed region is configured to allow blood exposure to ultraviolet radiation as blood flows through the chamber. The channel is
The inlet conduit;
The opening in the gasket;
The exposed area;
The other opening in the gasket;
The chamber of claim 3, wherein the chamber is configured to allow blood flow through the outlet conduit.   The chamber of claim 1, wherein the channel is configured to allow blood flow at a rate in the range of 0.1 to 5 milliliters per minute.   The chamber of claim 1, wherein the channel is configured to allow blood flow at a rate in the range of 10 to 15 milliliters per minute.   The chamber of claim 1, wherein the channel is configured to allow blood flow at a rate of 1 milliliter per minute.   The chamber of claim 1, wherein the blood flowing through the exposure chamber is a component of blood.   The chamber of claim 1, wherein the width of the channel is 0.01 inches.   The chamber of claim 1, wherein the width of the channel is less than 0.005 inches.   The chamber of claim 1, wherein the channel width is in the range of 0.0005 to 0.002 inches.   The chamber of claim 1, wherein the UV filter lens is configured to prevent leakage of blood from the exposure chamber as blood flows from the channel. An exposure chamber for irradiating blood in a blood irradiation system, the blood irradiation system comprising:
UV light source of ultraviolet rays,
A connector between the UV light source and the exposure chamber;
A pump that pushes blood through the exposure chamber;
A shutter assembly provided between the UV light source and the exposure chamber for timed quantitative irradiation of the blood in the exposure chamber, the exposure chamber comprising:
A housing comprising a conduit;
Another housing comprising another conduit, the housing configured to be coupled to the other housing;
A gasket configured to be secured between the housing and the another housing and including an opening configured to be aligned with the conduit and the another conduit;
A filter lens configured to be fixed between the housing and the gasket;
Another filter lens configured to be secured between the another housing and the gasket;
An insert and another insert configured to be secured within the gasket, wherein both inserts form an exposed area within the gasket; and
An exposure chamber, wherein the conduit, the opening, and the exposure region form a channel configured to allow blood to flow through the exposure chamber.   14. The chamber of claim 13, wherein blood flows through the channel at a rate in the range of 10 to 15 milliliters per minute.   The chamber of claim 13, wherein blood flows through the channel at a rate in the range of 0.1 to 5 milliliters per minute.   14. The chamber of claim 13, wherein blood flows through the channel at a rate of 1 milliliter per minute.   14. The chamber of claim 13, wherein blood is exposed to UV light in the exposed area.   18. The chamber of claim 17, wherein the channel is configured such that unexposed blood enters the exposure chamber through the conduit and exposed blood exits the exposure chamber through the another conduit. .   14. The chamber of claim 13, wherein the blood flows through the channel under pressure generated by a pump device configured to be coupled to the exposure chamber.   The chamber of claim 13, wherein the housing and the filter lens are configured to prevent blood leakage from the channel.   The insert and the other insert are provided with a multi-contour end and are configured to be secured within the gasket, the multi-contour end being further configured to form the exposed region within the gasket. 14. The chamber of claim 13, wherein the exposed region is configured to allow blood exposure to ultraviolet radiation as blood flows through the channel.   14. The chamber of claim 13, wherein the blood flowing through the exposure chamber is a blood component.   The chamber of claim 13, wherein the channel width is 0.01 inches.   The chamber of claim 13, wherein the channel width is less than 0.005 inches.   14. The chamber of claim 13, wherein the channel width is in the range of 0.0005 to 0.002 inches. A microchannel assembly for a blood irradiation device having an exposure chamber,
A conduit configured to be secured within the housing of the exposure chamber;
An opening in the gasket of the exposure chamber configured to communicate with the conduit;
An exposed area in the gasket configured to communicate with the opening;
Another opening in the gasket configured to communicate with the exposed area;
A microchannel assembly further configured to communicate with the another opening and secured to the housing. The microchannel channel is
The inlet conduit;
The opening in the gasket;
The exposed area; and
The further opening in the gasket;
27. The microchannel of claim 26, configured to allow blood flow through the outlet conduit.   27. The microchannel of claim 26, wherein blood flows through the microchannel at a rate in the range of 10 to 15 milliliters per minute.   27. The microchannel of claim 26, wherein blood flows through the microchannel at a rate in the range of 0.1 to 5 milliliters per minute.   27. The microchannel of claim 26, wherein blood flows through the microchannel at a rate of 1 milliliter per minute.   27. The microchannel of claim 26, wherein the blood flowing through the microchannel is a blood component.   27. The microchannel of claim 26, wherein the microchannel width is 0.01 inches.   27. The microchannel of claim 26, wherein the microchannel width is less than 0.005 inches.   27. The microchannel of claim 26, wherein the microchannel width is in the range of 0.0005 to 0.002 inches.

Images