CA2480570A1 - Method for collecting a desired blood component and performing a photopheresis treatment - Google Patents

Abstract

An improved method for separating whole blood into components and collecting a desired blood component. The method allows a desired blood component to be subjected to centrifugal forces within a separator for prolonged periods of time, yieldin g a cleaner cut and higher yield of the desired blood component. Whole blood is drawn from a source and pumped into a separator, the undesired blood components are removed from the separator at rates so as to build up the desired blood component in the separator. The desired blood component is only removed after a predetermined amount of the desired blood component has built up in the separator. It is preferred that the desired blood component be buffy coat and that the method be used to perform photopheresis treatments. In another aspect, the invention is a method of performing a full photopheresis treatment to treat diseases in a reduced time, preferably less than about 70 minutes, and more preferably les s than about 45 minutes.

Description

METHOD FOR COLLECTING A DESIRED BLOOD COMPONENT AND
PERFORMING A PHOTOPHERESIS TREATMENT
Cross-Reference to Related Auplications (0001] This application is a continuation-in-part application of United States Patent Application 101375,628, filed February 27, 2003, which claims the benefit of United States Provisional Application, Serial Number 60/361,287, filed March 4, 2002, both of which are hereby incorporated by reference in their entireties. , Technical Field of the Invention

[0002] The present invention relates generally to methods for separating whole blood into blood components and collecting a desired blood component, and specifically to methods of treating diseases with a photopheresis treatment.
BackEround of the Invention

[0003] Several treatments for disease require the removal of blood from a patient, processing the one or more components of the blood, and return of the processed components for a therapeutic effect. Those extracorporeal treatments require systems for safely removing blood from the patient, separating it into components, and returning the blood or blood components to the patient.. With the advance of medical sciences, it has become possible to treat a patient's.blood in closed-loop processes, returning the patient's own treated blood back to him in one medical treatment. An example of such processes include external treatment methods for diseases in which there is a pathological increase of lymphocytes, such as cutaneous T-cell lymphoma or other diseases affecting white blood cells. In such methods, the patient's blood is irradiated with ultraviolet light in the presence of a chemical or an .
antibody. Ultraviolet light affects the bonding between the lymphocytes and the chemical or antibody that inhibits the metabolic processes of the lymphocytes.

[0004] Photopheresis systems and methods have been proposed and used which involve separation of huffy coat from the blood, addition of a photoactivatable drug, and UV
irradiation of the huffy coat before re-infusion to the patient.
Extracorporeal photopheresis may be utilized to treat numerous diseases including Graft-versus-Host disease, Rheumatoid Arthritis, Progressive Systematic Sclerosis, Juvenile Onset Diabetes, Inflammatory Bowel Disease and other diseases that are thought to be T-cell or white blood cell mediated, including cancer. Apheresis systems and methods have also been proposed and used which involve separation of blood into various components.

[0005) During one of these medical treatments, a centrifuge bowl, such as, for example, a Latham bowl, as shown in U.S. Patent No. 4,303,193, expressly incorporated by reference in its entirety herein, is operated to separate whole blood into red blood cells ("RBCs"), plasma, and buffy coat. The Latham bowl is a blood component separator that has been used for some time in the medical apheresis market as well as in innovative medical therapies such as extracorporeal photopheresis (ECP). PCT Applications WO 97/36581 and WO
97/36534, and U.S. Patent Nos. 4,321,919; 4,398,906; 4,428,744; end 4,464,166 provide descriptions of extracorporeal photopheresis, and are hereby expressly incorporated by reference in their entirety.

[0006) Latham bowl efficiency is often measured by the white blood cell ("WBC") "yield,"
which is typically about 50%. Yield is defined as the percentage of cells collected versus the number processed. When compared to other types of whole blood separators, this high yield enables the Latham bowl separator to collect much larger volumes of WBCs while processing much less whole blood from the donor patient. However, a major drawback to the Latham bowl separator is that the separation process must be repeatedly stopped to remove the packed ltBCs and plasma once they fill the inside of the bowl, creating a "batch-type"
treatment process. Although the Latham bowl separator has a high volume yield, the constant filling and emptying of this bowl wastes time; thus, the process is considered less efficient with respect to time.

[0007) Prior photopheresis and apheresis systems and methods usually require batch processes and therefore take several hours to treat a patient or to obtain a sufficient supply of separated blood fragments. Furthermore, the systems are very complex to manufacture. It is a constant objective to reduce the time it takes to perform a complete photopheresis treatment session. Another objective is to reduce the amount of blood that must be drawn form a patient and processed in closed-loop processes per photopheresis treatment session. Yet another objective to increase the amount of white blood cell yield or obtain a cleaner cut of buffy coat per volume of whole blood processed.
Disclosure of the Invention

[0008) An object of the present invention is to provide an improved method for separating a fluid, such as blood or other biological fluid, into its components. An additional object is to increase the efficiency of current fluid separation processes by decreasing the time necessary to separate out a desired amount of a fluid component from the fluid. Yet other objects ofthe present invention are to treat a patient more efficiently, to improve a photopheresis process, or to improve a platelet removal process. An additional object of the present invention is to separate and remove targeted cells by their specific gravity. Another object of the present invention is to eliminate the need to perform fluid separation processes in "batch" form. A
still further object of the present invention is to increase the percent yield of a desired fluid component from a fluid being separated.

[0009] The present invention solves the inadequacies of the prior art by being able to continuously separate fluid components without interrupting the process to empty a centrifuge bowl and remove a separated component. Thus, the present invention eliminates batch processing and other Latham bowl batch-type techniques. These objects and others are met by the present invention which is directed at improving the methods for separating whole blood into its components and collecting a desired blood component. Depending on the intended treatment, the desired blood component may be huffy coat, red blood cells, plasma, or any component thereof. The present invention is also directed at improving existing methods of treating diseases using photopheresis therapies. Specifically, the present invention provides a continuous process for whole blood separation of sufficient fragment for photopheresis treatment so as to greatly reduce the photopheresis treatment time for a patient.
[001 OJ When it is desired to collect huffy coat from whole blood, the invention in one aspect is a method comprising: providing a separator having an inlet, a first outlet, and a second outlet; drawing whole blood from a source; adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid; pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate; separating the mixture into blood components of different densities;
withdrawing plasma and red blood cells from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and red blood cells being withdrawn at rates so as to build up huffy coat in the separator, the plasma being withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet;
and upon a predetermined amount of huffy coat building up in the separator, collecting the huffy coat from the separator.
[0011] By withdrawing the red blood cells and the plasma at rates so that the huffy coat is allowed to build up within the separator, which is preferably a centrifuge bowl, the huffy coat is subjected to the centrifugal force of the separator for a prolonged period of time.
Increasing the time which the huffy coat is subjected to centrifugal force yields a cleaner fraction of huffy coat and an increased white blood cell yield. Additionally, this prolonged exposure can be used to further separate the huffy coat into its constituent parts, including platelets and various kinds of leukocytes.
(0012] When pumping the mixture of whole blood and anticoagulant fluid into the separator, it is preferred that the mixture pass through, and be routed by, a cassette for controlling fluid flow. It is further preferable that the huffy coat be collected from the separator by discontinuing the withdrawal of red blood cells from the second outlet, thereby causing the red blood cells to push the huffy coat out of the separator via the first outlet as whole blood continues to enter the separator. The withdrawn huffy coat can be collected in a treatment bag that is fluidly connected to the separator via an outlet line. In this embodiment, the collection of huffy coat is preferably discontinued when red blood cells are detected in the outlet line. This will minimize red blood cells from being mixed with the desired huffy coat.
[0013] In performing this method, it is also preferable that only the plasma be withdrawn from the separator until a predetermined amount of red blood cells are detected in the separator. Then, upon the predetermined amount of red blood cells being detected in the separator, the red blood cells will be drawn from the separator at a rate so as to maintain the amount of red blood cells present in the separator at approximately the predetermined amount. The predetermined amount of red blood cells can be detected using a hematocrit sensor that can detect a red cell line within the centrifuge bowl itself.
[0014] When the method is being used in a closed loop process where the source of the whole blood is a patient, it is important to return fluids back to the patient during processing.
In order to achieve this, it is preferable that the withdrawn plasma be collected in a plasma storage bag, mixed with a priming fluid, and returned to the patient when a selected amount of plasma is collected in the plasma storage bag. It is further preferable to mix the withdrawn red blood cells with the plasma and priming fluid mixture from the plasma collection bag and returning the red blood cell-plasma-priming fluid mixture to the patient at a rate approximately equal to the inlet rate.
[0015] This method can be used in connection with photopheresis treatment. In a photopheresis treatment, the method will further comprise injecting a photoactivation chemical into the collected huffy coat, and irradiating the collected huffy coat within an irradiation chamber until a predetermined amount of energy has been transferred to the collected huffy coat. In order to ensure that a proper amount of energy is transferred to the huffy coat, for example to induce apoptosis, it is preferable to recirculate the collected huffy coat between a treatment bag and the irradiation chamber. Before the irradiated huffy coat is returned to the patient undergoing the photopheresis therapy, the irradiated huffy coat should pass through a filter. Using this method, enough huffy coat can be collected and irradiated to perform a full photopheresis treatment in less than about 70 minutes. More preferably, the overall treatment time is less than about 45 minutes.
[0016] It may also be desired to collect the red blaod cells from the separator for other types of treatments. Because the red blood cells can be subjected to prolonged centrifugal force, the current method provides a very packed amount of red cells. These red blood cells can be withdrawn and collected for further use, such as in apheresis therapy.
[0017] In yet another aspect, the invention is a method of performing a photopheresis treatment for ameliorating diseases. This method comprises: drawing whole blood from a source; adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of the whole blood and the anticoagulant fluid; separating the mixture of whole blood and anticoagulant into a plurality of blood components according to density;
mixing a photoactivation chemical with at least one the blood components to form a mixture of the photoactivation chemical and the at least one blood component; irradiating the combination of the at least one blood component and photoactivation chemical; and returning the irradiated combination to a patient; wherein the entire photopheresis treatment is completed in less about than 70 minutes. More preferably, the entire photopheresis treatment is completed in less about than 45 minutes. This is a vast improvement over previous photopheresis treatments which usually required a treatment time of two hours or more.
[0018] In this aspect of the invention, the at least one blood component can be huffy coat, a leukocyte, or platelets. Buffy coat is preferred. In performing the photopheresis treatment, the mixture of whole blood and anticoagulant fluid is preferably pumped into a separator having an inlet, a first outlet, and a second outlet. Because huffy coat is the desired blood component in a photopheresis therapy session, plasma and red blood cells are withdrawn from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator. The plasma and red blood cells are preferably withdrawn at rates so as to build up huffy coat in the separator, allowing the huffy coat to be exposed to prolonged centrifugal forces. The plasma is withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet. Buffy coat is preferably collected from the separator for irradiation only after a predetermined amount of huffy coat builds up therein.
[0019] The separated huffy coat is preferably collected from the separator through an outlet line that is fluidly connected to a treatment bag. The huffy coat can be collected from the separator by discontinuing the withdrawal of red blood cells from the second outlet while continuing to pump in whole blood. This causes the red blood cells to push the huffy coat out of the separator via the first outlet. Buffy coat collection is preferably stopped when red blood cells are detected in the outlet Iine by a hematocrit sensor. The collected huffy coat is preferably irradiated within an irradiation chamber until' a predetermined amount of energy has been transferred to the collected huffy coat. The predetermined amount of energy is preferably sufficient to induce apoptosis.
[0020) This photopheresis treatment is preferably performed in a closed-loop system where the patient is also the source. Finally, instead of separating only huffy coat, the huffy cells cari be further separated if desired into their components such as platelets and leukocytes. .
[0021] Finally, an effective method of collecting red blood cells is achieved by another aspect of the invention which is a method of collecting a desired blood component comprising: providing a separator having an inlet, a first outlet, and a second outlet; drawing whole blood from a source; adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;
pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate; separating the mixture into blood components of different densities; withdrawing plasma and huffy coat from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and huffy coat being withdrawn at rates so as to build up red blood cells in the separator, the plasma and huffy coat being withdrawn via the first outlet; and upon a predetermined amount of red blood cells building up in the separator, collecting the red blood cells from the separator via the second outlet.
This method allows the red blood cells to build up in the separator and be subjected to a maximum amount of prolonged centrifugal force Brief Description of the Drawings [0022] The invention is described in detail with respect to the accompanying drawings, which illustrate an embodiment of the inventive apparatus, assemblies, systems, and methods.

~, FIG. 1 is a schematic representation of an embodiment of a disposable kit for use in photopheresis therapy embodying features of the present invention.
FIG. 2 is an elevated perspective view of an embodiment of a cassette for controlling fluid flow in the disposable photopheresis kit of FIG. 1.
FIG. 3 is an exploded view of the cassette of FIG. 2.
FIG. 4 is a top view of the cassette of FIG. 2 with the cover removed and showing internal tubular circuitry.
FIG. S is a bottom view of a cover of cassette of FIG. 2.
FIG: 6 is an elevated perspective view of an embodiment of a filter assembly..
FIG. 7 is bottom perspective view of the filter assembly of FIG. 6.
FIG. 8 is an exploded view of the filter assembly of FIG. 6.
FIG. 9 is a rear perspective view of the filter assembly of FIG. 6.
FIG. 10 is schematic representation of the filter assembly of FIG. 6 coupled to pressure sensors and a data processor.
FIG. 11 is a front view of an irradiation chamber.
FIG. 12 is a side longitudinal view of the irradiation chamber of FIG. 11.
FIG. 13 is a side transverse view of the irradiation chamber of FIG. 11 FIG. 14 is a cut-away view of a section of the first plate and the second plate prior to being joined together to form the irradiation chamber of FIG. 11.
FIG. 15 is a cut-away dimensional end view of the irradiation chamber of FIG.
11.
FIG. 16 is a perspective view of the irradiation chamber of FIG. 11 positioned within a UVA light assembly.
FIG. 17 is an elevated perspective view of an embodiment of a permanent tower system for use in conjunction with a disposable kit for facilitating a photopheresis therapy session.
FIG. 18 is a cross-sectional view of an embodiment of the photoactivation chamber, without a UVA light assembly, used in the tower system of FIG. 17.
FIG. 19 is a cross-sectional view of an embodiment of the centrifuge chamber used in the tower system of FIG. 17.
FIG. 20 is an electrical schematic of the leak detection circuit provided in the photoactivation chamber of FIG. 18.
FIG. 21 is an electrical schematic of the leak detection circuit provided in the centrifuge chamber of FIG. 19.

FIG. 22 is an elevated perspective view of an embodiment of the fluid flow control deck of the tower system of FIG: 17.
FIG. 23 is a perspective bottom view of the control deck of FIG. 22.
FIG. 24 is an exploded view of the control deck of FIG. 22.
FIG. 25 is a top perspective view of the control deck of FIG. 22 with the cassette of FIG.
2 loaded thereon.
FIG. 26 is a flowchart of an embodiment of a photopheresis treatment process.
FIG. 27 is a schematic of an embodiment of the fluid flow circuit used in performing the treatment process of FIG. 26. ' FIG. 28 is top perspective view an embodiment of a peristaltic pump.
FIG. 29 is a cross sectional side view of the peristaltic pump of FIG. 28.
FIG. 30 is a top perspective view the rotor of the peristaltic pump of FIG.
29.
FIG. 31 is a bottom perspective view of the rotor of FIG. 30.
FIG. 32 is a top view of the peristaltic pump of FIG. 28.
FIG. 33 is a top view of the peristaltic pump of FIG. 28 in a loading position and near the cassette of FIG. 2.
FIG. 34 is an electrical schematic of the infrared communication port circuit.
FIG. 35 illustrates an embodiment of a centrifuge bowl and a rotating frame.
FIG. 36 is a dimensional view of the bowl of FIG. 35.
FIG. 37 is an exploded view of the bowl of FIG. 36.
FIG. 38 shows a cross sectional view of the bowl of FIG. 36 along the line XIX-XIX.
FIG. 39A shows a cross sectional view of a connection sleeve in place with a lumen connector of the bowl of FIG 38 along the line XX.
FIG. 39B shows another cross sectional view of a connection sleeve in place with a lumen connector of the bowl of FIG 38.
FIG. 40 shows a cross sectional view of the top core of the bowl of FIG. 37.
FIG. 41 shows a dimensional view of the top core and upper plate of FIG. 37.
FIG. 42 shows a bottom view of the top core of FIG. 41.
FIG. 43A shows a dimensional exploded view of the bottom core and a lower plate of the bowl of FIG. 37.
FIG. 43B shows an dimensional cross section view of the bottom core and a lower plate of the bowl of FIG. 43A attached together.
FIG. 44 shows an exploded side view of the bottom core and a lower plate of FIG. 43A.
s FIG. 45 shows a dimensional view of another embodiment of a conduit assembly.
FIG. 46 shows a dimensional view of the connection sleeve of FIG. 45.
FIG. 47 shows a dimensional view of one end of conduit assembly of FIG. 45.
FIG. 48 shows a dimensional view of an anchor end of the ;present invention.
FIG. 49 shows a lateral cross-sectional view of an anchor end.
FIG. 50 shows a horizontal cross-sectional view of an anchor end taken along line XXI.
FIG. 51 illustrates a dimensional view of the rotating frame of FIG. 35.
FIG. 52 is an enlarged view of a holder for an external conduit.
FIG. 53 shows an alternative embodiment of the bowl with the cross-section taken similarly to that shown in FIG. 38.
FIG. 54 shows an alternative embodiment of the top core.
FIG. 55 shows an alternative embodiment of the connection sleeve.
Modes for Carrying Out The Invention [0023] Features of the present invention are embodied in the permanent blood driving equipment, the disposable photopheresis kit, the various devices which make up the disposable kit, and the corresponding treatment process. The following written description is outlined as follows:
I. Disposable Photopheresis Kit A. Cassette for Controlling Fluid Flow 1. Filter Assembly B. Irradiation Chamber C. Centrifuge Bowl 1. Drive Tube II. Permanent Tower System A Photoactivation Chamber B. Centrifuge Chamber C. Fluid Flow Control Deck 1. Cassette Clamping Mechanism 2. Self Loading Peristaltic Pumps D. Infra-Red Communication III. Photopheresis Treatment Process [0024] The above-outline is included to facilitate understanding of the features of the present invention. The outline is not limiting of the present invention and is not intended to categorize or limit any aspect of the invention. The inventions are described and illustrated in sufficient detail that those skilled in this art can readily make and use them. However, various alternatives, modifications, and improvements should become readily apparent without departing from the spirit and scope of the invention. Specifically, while the invention is described in the context of a disposable kit and permanent blood drive system for use in photopheresis therapy, certain aspects of the invention are not so limited and are applicable to kits and systems used for rendering other therapies, such as apheresis or any other extracorporeal blood treatment therapy.
I. Disposable Photopheresis Kit [0025] FIG. 1 illustrates disposable photopheresis kit 1000 embodying features of the present invention. It is necessary that a new disposable sterile kit be used for each therapy session. In order to facilitate the circulation of fluids through photopheresis kit 1000, and to treat blood fluids circulating therethrough, photopheresis kit 1000 is installed in permanent tower system 2000 (FIG. 17). The installation of photopheresis kit 1000 into tower system 2000 is described in detail below.
(0026] Photopheresis kit I OOO comprises cassette 1100, centrifuge bowl 10, irradiation chamber700, hematocrit sensor l I25, removable data card 1195, treatment bag 50, and plasma collection bag 51. Photopheresis kit 1000 further comprises saline connector spike 1190 and anticoagulant connector spike 1191 for respectively connecting saline and anticoagulant fluid bags (not shown). Photopheresis kit 1000 has all the necessary tubing and connectors to fluidly connect all devices and to route the circulation of fluids during a photopheresis treatment session. All tubing is sterile medical grade flexible tubing. Triport connectors 1192 are provided at various positions for the introduction of fluids into the tubing if necessary.
(0027) Needle adapters 1193 and 1194 are provided for respectively connecting photopheresis kit I 000 to needles for drawing whole blood from a patient and returning blood fluids to the patient. Alternatively, photopheresis kit 1000 can be adapted to use a single needle to both draw whole blood fram the patient and return blood fluids to the patient.
However, a two needle kit is preferred because of the ability to simultaneously draw whole blood and return blood fluids to the patient. When a patient is hooked up to photopheresis kit 1000, a closed loop system is formed.
[0028] Cassette 1100 acts both as a tube organizer and a fluid flow router.
Irradiation chamber 700 is used to expose blood fluids to UV light. Centrifuge bowl I O
separates whole blood into its different components according to density. Treatment bag 50 is a 1000mL
three port bag. Straight bond port 52 is used to inject a photoactivatable or photosensitive compound into treatment bag 50. Plasma collection bag 51 is 1000mL two port bag. Both treatment bag 50 and plasma collection bag 51 have a hinged cap spike tube 53 which can be used for drainage if necessary. Photopheresis kit 1000 further comprises hydrophobic filters 1555 and 1556 which are adapted to connect to pressure transducers 1550 and 1551 to filter 1500 via vent tubes 1552 and 1553 for monitoring and controlling the pressures within tubes connecting the patient (FIG. 10). Monitoring the pressure helps ensure that the kit is operating within safe pressure limits. The individual devices of photopheresis kit 1000, and their functioning, are discussed below in detail.
A. Cassette for Controlling Fluid Flow [0029] FIG. 2 shows a top perspective view of a disposable cassette 1100 for valuing, pumping, and controlling the movement of blood fluids during a photopheresis treatment session. Cassette 1100 has housing 1101 that forms an internal space that acts as a casing for its various internal components and tubular circuitry. Housing 1101 is preferably made of hard plastic, but can be made of any suitably rigid material. Housing 1101 has side wall 1104 and top surface 1105. Side wall 1104 of housing 1101 has tabs 1102 and 1103 extending therefrom. During a photopheresis treatment, cassette 1100 needs to be secured to deck 1200 of tower system 2000, as is best illustrated in FIG. 25. Tabs 1102 and 1103 help position and secure cassette 1100 to deck 1200.
[0030] Cassette 1100 has fluid inlet tubes 1106, 1107, 1108, 1109, 1110,1111, and 1112 for receiving fluids into cassette 1100, fluid outlet tubes 1114, 1115, 1116, 1117, 1118, and 1119 for expelling fluids from cassette 1100, and fluid inlet/outlet tube 1113 that can be used for both introducing and expelling fluids into and out of cassette 1100. These fluid input and output tubes fluidly couple cassette 1100 to a patient being treated, as well as the various devices of photopheresis kit 1000, such as centrifuge bowl 10, irradiation chamber700, treatment bag 50, plasma collection bag 51, and bags containing saline, anticoagulation fluid to form a closed-loop extracorporeal fluid circuit (FIG. 27).
[0031] Pump tube loops 1120, 1121, 1122, 1123, and 1124 protrude from side wall 1104 of housing 1101. Pump tube loops 1120, 1121, 1122,1123, and 1124 are provided for facilitating the circulation of fluids throughout photopheresis kit 1000 during therapy. More specifically, when cassette 1100 is secured to deck 1200 for operation, each one of said pump tube loops 1120, 1121, 1122, 1123, and 1124 are loaded into a corresponding peristaltic pump 1301, 1302, 1303, 1304, and 1305 (FIG. 4). Peristaltic pumps 1301, 1302, 1303, 1304, and 1305 drive fluid through the respective pump tube loops 1120,1121,1122,1123, and 1124 in a predetermined direction, thereby driving fluid through photopheresis kit 1000 (FIG.
1) as necessary. The operation and automatic loading and unloading of peristaltic pumps 1301, 1302, 1303,1304, and 1305 is discussed in detail below with respect to FIGS. 28-33.
[0032] Turning now to FIG. 3, cassette 1100 is shown with housing 1101 in an exploded state. For ease of illustration and description, the internal tubular circuitry within housing 1101 is not illustrated in FIG. 3. The internal tubular circuitry is illustrated in FIG. 4 and will be discussed in relation thereto. Cassette 1100 has filter assembly 1500 positioned therein and in fluid connection with inlet tube 1106, outlet tube' l 114, and one end of each of pump tube loops 1120 and 1121. Filter assembly 1500 comprises vent chambers 1540 and 1542.
Filter assembly 1500, and its functioning, is discussed in detail below with respect to FIGS.
6-10.
[0033] Housing 1101 comprises cover 1130 and base 1131. Cover 1130 has top surface 1105, a bottom surface 1160 (FIG. 5), and side wall 1104. Cover 1130 has openings 1132 and 1133 for allowing vent chambers 1540 and 1542 of filter assembly 1500 to extend therethrough. Side wall 1104 has a plurality of tube slots 1134 to allow the inlet tubes, outlet tubes, and pump loop tubes to pass into the internal space of housing 1101 for connection with the internal tubular circuitry located therein. Only a few tube slots 1134 are labeled in FIG. 3 to avoid numerical crowding. Tabs 1102 and 1103 are positioned on side wall 1104 so as not to interfere with tube slots 1134. Cover 1130 has occlusion bars 1162 and 1162A
extending from bottom surface 1160 (FIG. 5). Occlusion bars 1162 and 1162A are preferably molded into bottom surface 1160 of cover 1130 during its formation.
[0034] Base 1131 has a plurality ofU-shaped tube-holders 1135 extending upward from top surface 1136. U-shaped tube holders 1135 hold the inlet tubes, outlet tubes, pump loop tubes, filter assembly, and internal tubular circuitry in place. Only a few U-shaped holders 1135 are labeled in FIG. 3 to avoid numerical crowding. Preferably, a U-shaped holder 1135 is provided on base 1131 at each location where an inlet tube, an outlet tube, or a pump loop tube passes through a tube slot 1134 on side wall 1104. Male extrusions 1136 protrude from top surface 1136 of base 1131 for mating with corresponding female holes 1161 located on bottom surface 1160 of cover 1130 (FIG. 5). Preferably, a male protrusion 1136 is located at or near each of the four corners of base 1130 and near filter 1500. Male protrusions 1136 mate with the female holes 1161 to form a snap-fit and secure base 1131 to cover 1130.

[0035] Base 1131 further comprises a hub 1140. Hub 1140 is a five-way tube connector used to connect five tubes of the internal tubular circuitry. Preferably, three apertures 113? are located near and surround three of the tubes leading into hub 1140. Hub I 140 acts as a centralized junction which can be used, in conjunction with compression actuators 1240-1247 (FIG. 22), to direct fluids through photopheresis kit 1000 and to and from the patient. In addition to hub 1140, appropriate tube connectors, such as T-connectors 1141 and Y-connector 1142, are used to obtain the desired flexible tubing pathways.
(0036] Five apertures 1137 are located on the floor of base 1130. Each aperture 1137 is surrounded by an aperture wall 1138 having slots 1139 for passing portions of the internal tubular circuitry therethrough. An elongated aperture 1157 is also provided on the floor of base 1131. Apertures 1137 are located on base 1131 to align with corresponding compression actuators 1243-1247 of deck 1200 (FIG. 22). Aperture 1157 is located on base 1131 to align with compression actuators 1240-1242 of deck 1200 (FIG. 22).
Each aperture II37 is sized so that a single compression actuator 1243-1247 can extend therethrough.
Aperture 1157 is sized so that three compression actuators 1240-1242 can extend therethrough. Compression actuators 1240-1247 are used to close/occlude and open certain fluid passageways of the internal tubular circuitry in order to facilitate or prohibit fluid flow along a desired path. When it is desired to have a certain passageway open so that fluid can flow therethrough, the compression actuator 1240-1247 for that passageway is in a lowered position However, when it is desired to have a certain fluid passageway closed so that fluid can not flow therethrough, the appropriate compression actuator 1240-1247 is raised, extending the compression actuator 1240-1247 through aperture 1137 or 1157 and compressing a portion of the flexible tubular circuitry against bottom surface 1160 (FIG. 5) of cover 1130, thereby closing that passageway. Preferably, occlusion bars I
163 and 1173 (FIG. 5) are positioned on bottom surface 1160 to align with the compression actuators 1240-1247 so that the portion of flexible tubing being occluded is compressed against occlusion bar 1163 or 1173. Alternatively, the occlusion bar can be omitted or located on the compression actuators themselves.
[0037] It is preferable for cassette 1100 to have a unique identifier that can communicate with and relay information to permanent tower system 2000. The unique identifier is provided to ensure that the disposable photopheresis kit is compatible with the blood drive equipment into which it is being loaded, and that the photopheresis kit is capable of running the desired treatment process. The unique identifier can also be used as a means to ensure that the disposable photopheresis kit is of a certain brand name or make, In the illustrated example, the unique identifier is embodied as data card 1195 (FIG. 2) that is inserted into data card receiving port 2001 of permanent tower system 2000 (FIG. 17). Data card 1195 has both read and write capabilities and can store data relating to the treatment therapy performed for future analysis. The unique identifier can also take on a variety of forms, including, for example, a microchip that interacts with the blood drive equipment when the kit is loaded, a bar code, or a serial number.
(0038] Cover 1130 has data card holder 1134 for holding data card 1195 (FIG.
1). Data card holder 1134 comprises four elevated ridges in a segmented rectangular shape for receiving and holding data card 1 I95 to cassette 1100. Data card holder 1134 holds data card 1195 in place via a snap-fit (FIG. 2).
[0039] Refernng now to FIGS, l and 4, the internal tubular circuitry of cassette 1100 will now be discussed. At least a portion of the internal tubular circuitry is preferably made of flexible plastic tubing that can be pinched shut by the exertion of pressure without compromising the hermetic integrity of the tube. Base 1131 of cassette 1100 is illustrated in FIG. 4 so that the internal tubular circuitry can be viewed. Inlet tubes 1107 and 1108 and outlet tube 1115 are provided for coupling cassette 1100 to centrifuge bowl 10 (FIG. 1).
More specifically, outlet tube l I15 is provide for delivering whole blood from cassette 1100 to centrifuge bowl 10, and inlet tubes I 107 and 1108 are respectively provide for returning a lower density blood components and higher density blood components to cassette l I00 for further routing through photopheresis kit 1000. The lower density blood components can include, for example, plasma, leukocytes, platelets, huffy coat, or any combination thereof.
The higher density components can include, for example, red blood cells.
Outlet tube 1117 and inlet tube 1112 fluidly couple cassette 1100 to irradiation chamber 700.
More specifically, outlet tube 1 I I? is provided for delivering an untreated lower density blood component, for example huffy coat, to irradiation chamber700 for exposure to photo energy, while inlet tube 1112 is provided for returning the treated lower density blood component to cassette 1100 for further routing.
j0040] Inlet tube 1111 and outlet tube 1116 couple treatment bag 50 to cassette 1100. Outlet tube 1116 is provided to deliver an untreated low density blood component, for example huffy coat, to treatment bag 50. Outlet tube 1116 has hematocrit ("HCT") sensor 1125 operably connected thereto to monitor for the introduction of a high density blood component, such as red blood cells. HCT sensor I 125 is a photo sensor assembly and is operably coupled to a controller. HCT sensor 1125 sends a detection signal to the controller when red blood cells are detected in outlet tube l 116 and the controller will take the appropriate action. Inlet tube 1111 is provided to return the untreated low density blood component from treatment bag 50 to cassette 1100 for further routing. Inlet tubes 1109 and 1 I 10 are respectively connected to a saline and anticoagulant storage bags (not shown) via spikes 1190 and 1191 and are provided for delivering saline and an anticoagulant fluid to cassette 1100 for further routing to the patient.
[0041] Inlet/Outlet tube 1113 and outlet tube 1118 couple plasma collection bag 50 to cassette 1100. More specifically, outlet tube 1118 delivers a blood component, such as plasma, to plasma collection bag 51. InletIUutlet tube 1113 can be used to either deliver red blood cells to plasma collection bag 51 from cassette 1100 or return the blood components) that build up in plasma collection bag 51 to cassette 1100 for further routing. Inlet tube 1106 and outlet tubes 1119 and 1114 are coupled to a patient. Specifically, outlet tube 1114 is provided to return treated blood, saline, untreated blood components, treated blood components, and other fluids back to the patient. Inlet tube 1106 is provided for delivering untreated whole blood (and a predetermined amount of an anticoagulant fluid) from the patient to cassette 1100 for routing and treatment within photopheresis kit 1000. Outlet tube 1119 is specifically provided for delivering an anticoagulant fluid to inlet tube 1106. It is preferable that all tubing is disposable medical grade sterile tubing.
Flexible plastic tubing is the most preferred.
(0042] Cassette 1100 has five pump tube loops 1120, 1121,1122,1123, and 1124 for driving blood fluids throughout cassette 1100 and photopheresis kit 1000. More specifically, pump tube loop 1121 loads into whole blood pump 1301 and respectively drives whole blood in and out of cassette 1100 via inlet tube 1106 and outlet tube 1115, passing through filter 1500 along the way. Pump loop tube l 120 loads into return pump 1302 and drives blood fluids through filter 1500 and back to the patient via outlet tube 1114. Pump loop tube 1122 loads into red blood cell pump 1305 and draws red blood cells from centrifuge bowl

10 and drives them into cassette 1100 via inlet line 1108. Pump loop tube 1123 loads into anticoagulant pump 1304 and drives an anticoagulant fluid into cassette 1100 via inlet tube 1124 and out of cassette 1100 to via outlet tube 1119, which connects with inlet tube 1106.
Pump loop tube 1124 loads into recirculation pump 1303 and drives blood fluids, such as plasma, through treatment bag 50 and irradiation chamber700 from cassette 1100.

[0043] Each of peristaltic pumps 1301-1305 are activated when necessary to perform the photopheresis treatment therapy according to an embodiment of the method of the present invention which is described below in relation to FIGS. 26-27. Peristaltic pumps 1301-1305 can be operated one at a time or in any combination. The pumps 1301-1305 work in conjunction with compression actuators 1240-1247 to direct fluids through desired pathways of photopheresis kit 1000. Apertures 1137 and 1157 are strategically located on base 1131 along the internal tubular circuitry to facilitate proper routing. Through the use of compression actuators 1240-1247, the fluids can be directed along any pathway or combination thereof.
1. The Filter Assembly [0044] Filter 1500, which is located within cassette 1100 as described above, is illustrated in detail in FIGS. 6-10. Referring first to FIGS. 6 and 7, filter 1500 is illustrated fully assembled. Filter 1500 comprises a filter housing 1501. Filter housing 1501 is preferably constructed of a transparent or translucent medical grade plastic. However, the invention is not so limited and filter housing 1501 can be constntcted of any material that will not contaminate blood or other fluids that are flowing therethrough.
[0045] Filter housing 1501 has four fluid connection ports extruding therefrom, namely whole blood inlet port 1502, whole blood outlet port 1503, treated fluid inlet port 1504, and treated fluid outlet port 1505. Ports 1502-1505 are standard medical tubing connection ports that allow medical tubing to be fluidly connected thereto. Ports 1502-1505 respectively contain openings 1506,1507,1508 and 1509. Qpenings 1506,1507,1508 and 1509 extend through ports 1502, 1503, I 504 and I 505, forming fluid passageways into filter housing 1501 at the desired locations.
[0046] Ports 1502,1503, 1504 and 1505 are also used to secure filter 1500 within cassette 1100. In doing so, ports 1502, 1503,1504 and 1505 can engage U-shaped fasteners 1135 of cassette 1100 (FIG. 3). Filter housing 1501 also has a protrusion 1510 extending the bottom surface of housing floor 1518. Protrusion 1510 fits into a guide hole of base 1131 of cassette 1100 (FIG. 3).
[0047] Referring now to FIG. 8, f lter 1500 is illustrated in an exploded state. Filter housing 1501 is a two-piece assembly comprising roof 1511 and base 1512. Roof 1511 is connected to base 1512 by any means known in the art, such as ultrasonic welding, heat welding, applying an adhesive, or by designing roof 1511 and base I5I2 so that a tight fit results between the two. While filter housing 1501 is illustrated as a two-piece assembly, filter housing 1501 can be either a single piece structure or a multi-piece assembly.
[0048] Base 1512 has chamber separation wall 1513 extending upward from a top surface of housing floor 1518 (FIG. 7). When base 1512 and roof 1511 are assembled, top surface 1515 of chamber separation wall 1513 contacts the bottom surface of roof 151 i, forming two chambers within the filter housing, whole blood chamber 1516 and filter chamber 1517.
Fluid can not directly pass between whole blood chamber I516 and filter chamber 1517.
[0049] Whole blood chamber 1516 is a substantially L-shaped chamber having floor 1514.
Whole blood chamber 1516 has a whole blood inlet hole 1519 and a whole blood outlet hole (not illustrated) in floor 1514. Whole blood inlet hole 1519 and the whole blood outlet hole are located at or near the ends of the substantially L-shaped whole blood chamber 1516.
Whole blood inlet hole 1519 forms a passageway with opening 1506 of inlet port 1502 so that a fluid can flow into whole blood chamber 1516. Similarly, the whole blood outlet hole (not illustrated) forms a passageway with opening 1507 of outlet port 1503 so that fluid can flow out of whole blood chamber 1516.
[0050] Filter chamber 1517 has floor 1520. Floor 1520 has elevated ridge 1521 extending upward therefrom. Elevated ridge 1521 is rectangular and forms a perimeter.
While elevated ridge 1521 is rectangular in the illustrated embodiment, elevated ridge 1521 can be any shape so long as it forms an enclosed perimeter. The height of elevated ridge I521 is less than the height of chamber separation wall 1513. As such, when roof 1511 and base 1512 are assembled, space exists between the top of elevated ridge 1521 and the bottom surface of roof 1511. Elevated ridge 1521 and chamber separation wall 1513 form a trench 1524 there between.
[0051] In order to facilitate fluid flow through filter chamber 1517, floor 1520 of filter chamber 1517 has treated fluid inlet hole 1522 and treated fluid autlet hole 1523. Treated fluid inlet hole 1522 is located exterior of the perimeter formed by elevated ridge 1521 and forms a passageway with opening 1508 of inlet port 1504 sa that a fluid can flow into filter chamber 1517 from outside filter housing 1501. Treated fluid outlet hole 1523 is located interior of the perimeter formed by elevated ridge 1521 and forms a passageway with opening 1509 of outlet port 1505 so that a fluid can flow out of filter chamber 1517.
[0052] Filter 1500 further comprises filter element 1530. Filter element 1530 comprises frame 1531 having filter media 1532 positioned therein. Frame 1531 has a neck 1534 that forms a filter inlet hole 1533. Filter element 1530 is positioned in filter chamber 1517 so that frame 1531 fits into trench 1.524 and neck 1534 surrounds treated blood inlet hole 1522.
Filter inlet hole 1533 is aligned with treated fluid inlet hole 1522 so that incoming fluid can freely flow through holes 1522 and 1533 into filter chamber I5I7. Frame 1531 of filter element 1530 forms a hermetic fit with elevated ridge 1521. All fluid that enters filter chamber 1517 through holes 1522 and 1533 must pass through filter media 1532 in order to exit filter chamber 1517 via treated fluid outlet hole 1523. Filter media 1532 preferably has a pore size of approximately 200 microns. Filter media 1532 can be formed of woven mesh, such as woven polyester.
(0053] Filter chamber 1517 further comprises filter vent 'chamber 1540 within roof 1511.
Filter vent chamber 1540 has gas vent 1541 in the form of a hole (FIG. 9).
Because gas vent 1541 opens into filter vent chamber 1540 which in turn opens into filter chamber 1517, gases that build-up within filter chamber 1517 can escape through gas vent 1541.
Similarly, whole blood chamber 1516 comprises blood vent chamber 1542 within roof 1511. Blood vent chamber 1541 has gas vent 1543 in the form of a hole. Because gas vent 1543 opens into blood vent chamber 1542 which in turn opens into whole blood chamber 1517, gases that build-up in whole blood chamber lSl6 can escape via gas vent 1543.
[0054] FIG. 10 is a top view of filter 1500 having pressure sensors 1550 and 1551 connected to gas vents 1541 and 1543. Pressure sensors 1550 and 1551 are preferably pressure transducers. Pressure sensor 1550 is connected to gas vent 1541 via vent tubing 1552. Vent tubing 1552 fits into gas vent 1541 so as to form a tight fit and seal.
Because gas vent 1541 opens into filter vent chamber 1540 which in turn opens into filtex chamber 1517, the pressure in vent tubing 1552 is the same as in filter chamber 1517. By measuring the pressure in vent tubing 1552, pressure sensor 1550 also measures the pressure within filter chamber 1517. Similarly, pressure sensor 1551 is connected to gas vent 1543 via vent tubing 1553. Vent tubing 1553 fits into gas vent 1543 so as to form a tight fit and seal and pressure sensor 1551 measures the pressure within whole blood chamber 1516. Filter vent chamber 1540 and blood vent chamber 1542 extend through openings 1132 and 1133 of cassette 1100 when filter 1500 is positioned therein (FIG. 2). This allows the pressure within chambers 1516 and 1517 to be monitored while still protecting filter chamber 1500 and the fluid connections thereto.
[0055] Pressure sensors 1550 and 1551 are coupled to controller 1554, which is a properly programmed processor. Controller 1554 can be a main processor used to drive the entire system or can be a separate processor coupled to a main processor. Pressure sensors 1550 and 1551 produce electrical output signals representative of the pressure readings within chambers 1517 and 1516 respectively. Controller 1554 receives on a frequent or continuous basis data representing the pressure within chambers 1516 and 1517. Controller 1554 is programmed with values representing desired pressures within chambers 1516 and 1517.
Controller 1554 continuously analyzes the pressure data it receives from pressure sensors 1550 and 1551 to determine whether the pressure readings are within a predetermined range from the desired pressure for chambers 1517 and 1516. Controller 1554 is also coupled to whole blood pump 1301 and return pump 1302. In response to the pressure data received from pressure sensors 1551 and 1550, controller 1554 is programmed to control the speed of whole blood pump 1301 and return pump 1302, thereby adjusting the flow rates through the pumps 1301 and 1301. Adjusting these flow rates in turn adjust the pressure within whole blood chambers 1516 and filter chamber 1517 respectively. It is in this way that the pressure within the lines drawing and returning blood to and from the patient is maintained at acceptable levels.
[0056] The functioning of filter 1500 during a photopheresis therapy session will now be discussed in relation to FIGS. 1, 6, and 10. While the functioning of filter 1500 will be described in detail with respect to drawing whole blood from a patient and returning a component of said whole blood back into the patient after it is treated, the invention is not so limited. Filter 1500 can be used in connection with almost any fluid, including red blood cells, white blood cells, huffy coat, plasma, or a combination thereof.
[0057] Whole blood pump 1601 draws whole blood from a patient who is connected to photopheresis kit 1000 via a needle connected to port 1193. The rotational speed of whole blood pump is set so that the pressure of the line drawing the whole blood from the patient is at an acceptable level. Upon being drawn from the patient, the whole blood passes into cassette I 100 via inlet tube I 106. Inlet tube 1106 is fluidly connected to inlet port 1502 of f Iter 1500. The whole blood passes through opening 1506 of inlet port 1502 and into L-shaped whole blood chamber 1516. The whole blood enters chamber 1516 through inlet hole 1519 which is located on floor 1514. As more whole blood enters chamber 1516, the whole blood spills along floor 1514 until it reaches the whole blood outlet hole (not illustrated) at the other end of L-shaped whole blood chamber 1516. As discussed above, the whole blood outlet whole forms a passageway with opening 1507 of outlet port 1503. The whole blood that is within chamber 1516 flows across floor 1514, through the whole blood outlet hole, into outlet port 1503, and out of filter 1500 through opening 1507.

[0058] As the whole blood passes through whole blood chamber 151, gases that are trapped in the whole blood escape. These gases collect in blood vent chamber 1542 and then escape via gas vent 1543. Pressure sensor 1551 continuously monitors the pressure within blood chamber 151b through vent tube 1553 and transmits corresponding pressure data to controller 1554. Controller 1554 analyzes the received pressure data and if necessary adjusts the speed of whole blood pump 1301, thereby adjusting the flow rate and pressure within chamber 1516 and inlet tube 1106. Controller 1554 adjust the pump speed to ensure that the pressure is within the desired pressure range.
[0059] The whole blood then exits filter 1500 through outlet port 1503 and ,passes out of cassette 1100 via outlet tube 1115. The whole blood is then separated into components and/or treated as described in detail below. Before being returned to the patient, this treated fluid (i.e. treated blood ox blood components) must be filtered. Untreated fluids such as red blood cells also must be filtered and will subjected to the below filtering process. The treated fluid is fed into filter chamber 1517 through opening 1508 of inlet port 1504.
Inlet port 1504 is fluidly connected to pump loop tube II20. The treated fluid enters filter chamber 1517 through inlet hole 1522 and passes through filter inlet hole 1533 of filter element 1530. The treated fluid fills filter chamber 151? until it spills over frame 1531 of filter element 1530, which is secured to elevated ridge 1521. The treated fluid passes through filter media 1532.
Filter media 1532 removes contaminants and other undesired materials from the treated fluid while at the same facilitating the release of trapped gases from the treated fluid. The treated fluid that passes through filter media 1532 gathers on floor 2 520 of filter chamber 1517 within the perimeter formed by elevated ridge 1521. This treated fluid then passes into treated fluid outlet hole 1523 and out of filter 1500 through opening 1506 of outlet port 1502.
The treated fluid is then returned to the patient via outlet tube 1114, which is fluidly connected to outlet port 1502. The treated fluid is driven through filter chamber 1517 and outlet tube l I I4 by return pump 1302.
[0060] Gases that are trapped in the treated fluid escape and collect in filter vent chamber 1540 as the treated fluid flows through filter chamber 1517. These gases then escape filter 1500 via gas vent 1541. Pressure sensor 1550 continuously monitors the pressure within filter chamber 1517 through vent tube 1552 and transmits corresponding pressure data to controller 1554. Controller 1554 analyzes the received pressure data and compares it to the desired pressure value and range. If necessary, controller 1554 adjusts the speed of return ao pump 1302, thereby adjusting the flow rate and pressure within chamber 1517 and outlet tube 1114.
B. Irradiation Chamber [0061] FIGS. 11-16 illustrate irradiation chamber700 of photopheresis kit 1000 in detail.
Referring first to Fig. 11, irradiation chamber700 is formed by joining two plates, a front and a back plate having a thickness of preferably about 0.06 in. to about 0.2 in., which are preferably comprised of a material ideally transparent to the wavelength of electromagnetic radiation. In the case of ultraviolet A radiation, polycarbonate has been found most preferred although other materials such as acrylic may be employed. Similarly, many known methods of bonding may be employed and need not be expanded on here.
[0062] The first plate 702 has a first surface 712 and a second surface 714.
in a preferred embodiment the first plate 702 has a first port 705 on a first surface 712, in fluid communications with the second surface 714. The second surface 714 of the first plate 702 has a raised boundary 726A defining an enclosure. The boundary 726A preferably extends substantially perpendicular from the second surface 714 (i.e, about 80-100 degrees).
Extending from the second surface 714 (preferably substantially perpendicularly) are raised partitions 720A. The boundary 726A surrounds the partitions 720A. One end of each partition 720A extends and contacts the boundary 726A.
[0063] The second plate 701 has a first surface 711 and a second surface 713.
In a preferred embodiment the second plate 701 preferably has a second port 730 on a first surface 711, in fluid communications with the second surface 713. The second surface 713 of the back plate 701 has a raised boundary 726B defining an enclosure. The boundary 726B
preferably extends substantially perpendicular from the second surface 713 (i.e. about 80-100 degrees).
Extending from the second surface 713 (preferably substantially perpendicular) are raised partitions (720B). The boundary 726B surrounds the partitions 720B. One end of each partition 720A extends and contacts one side of boundary (726B).
[0064) The joining of the second surfaces of the first and second plates results in a fluid tight junction between boundaries 726A and 726B thereby forming boundary 726.
Partitions 720A
and 720B are also joined forming a fluid tight junction thereby forming partition 720. The boundary 726 forms an irradiation chamber700 and together with the partitions 720 provides a pathway 710 having channels 715 for conducting fluid. The pathway maybe serpentine, zig-zag, or dove-tailed. Currently preferred is a serpentine pathway.

[0065] With reference to FIG. 11 and 12, irradiation chamber700 comprises a serpentine pathway 710 for conducting patient fluid, such as huffy coat or white blood cells, from inlet port 705 to outlet port 730, i.e., the serpentine pathway 710 is in fluid communication with inlet port 705 of front plate 702 and outlet port 730 of back plate 701.
Patient fluid is supplied from cassette 1100 to inlet port 705 via outlet tube 1117. After photoactivation and passing through serpentine pathway 710, the treated patient fluid is returned to cassette 1100 via inlet tube 1112 (FIGS. 1 and 4). The patient fluid is driven by xecirculation pump 1303.
Self shielding effects of the cells is reduced while the cells are photoactivated by irradiation impinging upon both sides of irradiation chamber700. ' [0066] Figure 11 shows pin 740 and recess 735 which align the two plates of irradiation chamber prior to being joined together in a sealing arrangement by RF welding, heat impulse welding, solvent welding or adhesive bonding. Joining of the plates by adhesive bonding and RF welding is more preferred. Joining of the front and back plates by RF
welding is most preferred as the design of the raised partitions 720 and perimeter 725 minimizes flashing and allows for even application of RF energy. Locations of pin 740 and recess 735 may be inside serpentine pathway 710 or outside of serpentine pathway 710. Figure 2 also shows a view of an irradiation chamber with axis L. Rotation of chamber 700180 degree about axis L gives the original configuration of the irradiation chamber. The irradiation chamber of the present invention has C2 symmetry about axis L.
[0067] Referring to FIGS. 11, 13, and 16, the leukocyte enriched blood, plasma, and priming solution are delivered through inlet port 705 of front plate 7U2 of irradiation chamber700 into channel 715. The channel 715 in the irradiation chamber700 is relatively °'thin" (e.g. on the order of approximately 0.04" as distance between two plates) in order to present large surface area of leukocyte rich blood to irradiation and reduce the self shielding effects encountered with lower surface area/volume ratios. The cross section shape of channel 715 is substantially rectangular (e.g. rectangular, rhomboidal or trapezoidal) which has as its long side the distance between partition 720 and the distance between the plates as its short side.
The shape of the cross section is designed for optimal irradiation of cells passing through channel 715. While a serpentine pathway 710 is preferred in order to avoid or minimize stagnant areas of flow, other arrangements are contemplated.
[0068] The irradiation chamber 700 allows efficient activation of photoactivatable agents by irradiation from a light array assembly, such as the PHOTOSETTE~'s two banks of WA
lamps (758) for activation (Figure 16). The irradiation plate and UVA light assembly (759) are designed to be used in a setting where edge 706 is oriented downward and edge 707 points upward. In this orientation, fluids entering input port 705 can exit from outlet port 730 with the aid of gravity. In the most preferred embodiment, irradiation of both sides of the.
irradiation chamber takes place concurrently while still permitting facile removal of the chamber. WA light assembly 759 is located within UV chamber 750 of permanent tower system 2000 (FIGS. 17 andl8).
(0069] The irradiation chamber's fluid pathway loops to form two or more channels in which the leukocyte-enriched blood is circulated during photoactivation by UVA
light. Preferably, irradiation chamber 700 has between 4 to 12 channels. More preferably, the irradiation chamber has 6 to 8 channels. Most preferably, the irradiation chamber has 8 channels.
[0070] Figure 14 shows cut-away views of the irradiation chamber. The channels 715 of serpentine pathway 710 are formed by the joining of raised partition 720 and perimeter 726 of the plates.
[0071] The irradiation chamber of the present invention can be made from a biocompatible material and can be sterilized by known methods such as heating, radiation exposure or treatment with ethylene oxide (ETO).
[0072] The method of irradiating cells using irradiation chamber 700 during extracorporeal treatment of cells with electromagnetic radiation (UVA) to be used in the treatment of a patient (such as to induce apoptosis in the cells and administer the cells into the patient) will now be discussed. Preferably the cells treated will be white cells.
[0073] In one embodiment of this method, a photoactivatable or photosensitive compound is first administered to at least a portion of the blood of a recipient prior to the extracorporeal treatment of the cells. The photoactivatable or photosensitive compound may be administered in vivo (e.g., orally or intravenously). The photosensitive compound, when administered in vivo may be administered orally, but also may be administered intravenously and/or by other conventional administration routes. The oral dosage of the photosensitive compound may be in the range of about 0.3 to about 0.7 mglkg., more specifically, about 0.6 mg/kg.
[0074] When administered orally, the photosensitive compound may be administered at least about one hour prior to the photopheresis treatment and no more than about three hours prior to the photopheresis treatment. If administered intravenously, the times would be shorter.
Alternatively, the photosensitive compound may be administered prior to or contemporaneously with exposure to ultraviolet light. The photosensitive compound may be administered to whole blood or a fraction thereof provided that the target blood cells or blood components receive the photosensitive compound. A portion of the blood could first be processed using known methods to substantially remove the erythrocytes and the photoactive compound may then be administered to the resulting enriched leukocyte fraction. In one embodiment, the blood cells comprise white blood cells, specifically, T-cells.
[0075] The photoactivatable or photosensitive compound may, in the case of some psoralens, be capable of binding to nucleic acids upon activation by exposure to electromagnetic radiation of a prescribed spectrum, e.g., ultraviolet light.
[0076] Photoactive compounds may include, but are not 'limited to, compounds known as psoralens (or furocoumarins) as well as psoralen derivatives such as those described in, for example, U.S. Pat. No. 4,321,919 and U.S. Pat. No. 5,399,719. The photoactivatable or photosensitive compounds that may be used in accordance with, the present invention include, but are not limited to, psoralen and psoralen derivatives; 8-methoxypsoralen;
4,5'8-trimethylpsoralen; 5-methoxypsoralen; 4-methylpsoralen; 4,4-dimethylpsoralen;
4-5'-dimethylpsoralen; 4'-aminomethyl-4,5',8-trimethylpsoralen; 4'-hydroxymethyl-4,5',8-trimethylpsoralen; 4',8-methoxypsaralen; and a 4'-(omega-amino-2-oxa) alkyl-4,5',8-trimethylpsoralen, including but not limited to 4'-(4-amino-2-oxa)butyl-4,5',8-trimethylpsoralen. In one embodiment, the photosensitive compound that may be used comprises the psoralen derivative, amotosalen (S-59) (Cerus, Corp., Concord, CA). See, e.g., U.S. Patent Nos. 6,552,286; 6,469,052; and 6,420,570. In another embodiment, the photosensitive compound that may be used in accordance with the invention comprises 8-methoxypsoralen.
[0077] Methoxsalen is a naturally occurring photoactive substance found in the seed of the Ammi majus (umbelliferae plant). It belongs to a class of compounds known as psoralens or furocournarins. The chemical name is 9-methoxy-7H-furo[3,2-g][I]-benzopyran-7-one. The formulation of the drug is a sterile liquid at a concentration of 20 mcg/mL in a 10 mL vial.
See http://www.therakos.com/TherakosUS/pdf/uvadexpi.pdf. Toxicology studies of extracorporeal photopheresis and different dosages of UVADEX~ and ultraviolet light in beagle dogs is located in the investigator's brochure.
[0078] Next, the portion of the subject's blood, recipient's blood, or the donor's blood to which the photoactive compound has been administered is treated by subjecting the portion of the blood to photopheresis using ultraviolet light. The photopheresis treatment may be carried out using long wavelength ultraviolet light (UVA) at a wavelength within the range of ,.';:. , .. ~:, ;t.:, ~ :~ ;, .: . . .; ~ . :'; ; vE, .' ~. , . .1 , _ ... ; ;.. ~: :, '.' ;.:' .:I. : _Y . ' . , . . ' . ~ ~ y ' . _ ~ ' . ~: ~ . ..
,y, ; ;_ .. . . ; . . ; ; . ' . , ;; , . , ' ,.
' X20 to 400.~a. Suc~r a raa~e is not Ii~iiiingy lsowevcr, but is axesely provided ~ a~~exa~le. . . , ' . ei~osur~e~tolultrar~iolet ii,~t.de~r~ tlae pho'~p3ig ttea~tent.ar~a.~'hh~.vi~~~ ion. of . ~ ; . .
. ~ui~t length to d~iv~r; far example about 1 Z Jtcnax to the blood. ~ ~ ~ . ~
. , , . ; , : .
~~. The. photopl~r~is, step is carrie~I Out' #s vitro by inst~tiia,~~
irrectiatioti '~ber'f00 : . ' ' : ' ~~
.~,~c, ~~to~av~tia~ c~am~er ~fsa ofpnt tower s~tem~zooo r~~s.' ~~ aid i$),, tn . ~ . . , ;
~v ~s.,.l~. .. ~ one ~n~ v.'WPbatop~resis step is carried'outtin ~ltro, ~,I~t~~Braotio~r of~e : . , ; .
. ... . . , , . . ..
~ Mood is returned to the sub3eckr~apie~t, or donor. ,T~ treated' blo~o~ of tho . ' ', . . ' a 1 ~ .~ .fed. leu~cyte fr~ion (as the caxe may be) may t~ be ~d b'~ ihe- ~ ' ~ ~ , ~ . . .
..;.-.. . . . . ;
'..i~,.',.~a7. '.y,. ~ .'~' ~~.~ . AI dVUIIf. . " . y . , . . .
;q. ' , .. . , 'Y. ~ : ~ . ' . C :, ', ~~ . Q~'K1'aD~~'08i8 p~'~S C0~1~13~ Of #plltOli: ~'. t118 f~0~0~! O~
a ~ . , , .'''c>: ia,.~ , .; . . , , i., . . .. . , .
v .<a ,~°. ' 7;-dD.~t-'~r~ion (ie~lcocyte~icbed), 2) irt'ecu1 of t~
colld'l~iffy.',.ca~t.oti, ;
~'. ~~ ~~'~ .,~d ~)~reision of~ea~ted wba#e ~rlood vas.. , This pmc~ss will be: ~ ~c~is<xid below in ~~ .~..~,: . ::: ~ v ~'~~rer.detsil. C~ly; whole blood is centred arid s~ in c,~~bo'wi~~.o; A ~~: . , ~, ', ' ; aotsl;o~'agproxiruataty'2~0 ml, of huffy poet and X00 of pla~na ere sep!d end saved for ~ ~ . . ' : ' .,~'; ~.;: ~.,,';~,''- :'" ~',." :'~:A iiv~ ~~ ~~~adi~oa. ' . : ~ ~ . : ~ ~ .
, . ' :: , '.: '., : , ., , , v . ' :. : , ' . '' .. .. v y .':o~.: .S. ::. . ..~. . .~ ~ . . . ~ . . . . ., , ;.~f ,'~Ie:COlle~cte$.pand bt~'y Coat at8 mixed'u~ttb l~eped u0r~s1 saline and ' ' ' ':. ~ , : :: . _ .
. ' ~~ I , ; ::~yADBX~?.. ('wetter valuble'S-~hoxypsof~lit~:), This mike flows aTr a 1.~4~ inure this layer ~ , _.:<::~'vv .~'''' ;~' :'.;:: :'' .the irradiation chamber of the irweotion.
The irradiation , ~~c~' ~'Otl, is , ~ . '. .
'r . .
j . ' ~, ' ~ . '~ ~ ~ . . , . 1; . ' . . , .: ..'t:. ..:; "~~ , .. .~ . . ' ' ' .
''' .'~!p'~080$V~OI! Clt~''~~I O~'IO'~V~' ~'S'Z~ b~v1'e~ tWOO:~~U~VA .. ' . .
: ' :;::: : ~:. ~ ~ ~ s'l~ftbe'1PH0'r'OQuEt"I~~ ~Fii~'. 'B~5). ~'I~~'OS':g'I"'1'E~
UVid1 lart~ps ~ 'fides. ' v . ~ . .', ~ ~ .
~ ; ' .: , , , : . . . , . ~ . .y . . . .
' ~.:,Of~thie.WA.-tc. ~'adiation ch~bes' 7x00, petcn~ttm8 exFosu~ to n~av~.~'t~A~iighi, . .
. :,. ; ; ". , : , , . , . ~
~~ ~ .:; .yi~~ing an aver;exposure per l~~Yte of I-a rta~, l~ouow~g.'~ie.
~otoactiv~tson ~, ~ . . ~ . .
:~ .~n.°.= . . r , :: ~:.p~i.~o'cells'::eore:rexuovod from the ixradiat~on chembet'rt~D. . .' .' ~ ~.
' .~':;'- ~';; :' .~ ~In~a ref~ed ernbodit oi".#lxe present invention the aells~~ai~~re. ~oved'byths Lori. ~ '. .. ' , .
~~v~ I~ . : . ;, . . . . .
.. ,.. , : . : ' ~'~: ~y , ~g ~tl~ chamber eie displaced ant the di~mbac with '',:.a..':;.~:~~. . ., .. . . : . ~ ~~ ' . ~ ~,..~1''~,uid selerxed.from'the group consisting Of$alin~r ples~ and co~nbinatis~ . , ' .. ' . ..
'. ; ,~~ ~ For'patiea~s who' are smell such as cS~iidren (e.g. taaidec 30'#x' ox ~'s~sn~ wb~ ' ~ ~ ".
.. . . .
.v~.cxiiar. is easily overloaded~with fluids t3~ an~o~ ofaddition~l f~~id usexl ~u wale ;: the,iriatio~ ~r will prefearai~ty 6e .not more 'than 2X the volume of~?die cb~r, w ' . ' .. ' 1;r . . ' ~e~~tyt~'mozp~tr 1X #~ v~~e ~f the~cba~nber~ v'~'l~'''' ,.tkea O:~X
,::. .,. ,~~p '. , . . ~ ~ =. , .
:: ~ ' ;..vQl~nevof~e c~~nb~ 0,25~L the volume of'th..e chamber., ~Tho ''~Oells voln~ne is ~ . ~. . , ~ . ' . ,.. ~ : . . . ~ ' ;,. ,t ~~ ~oo Cho pat'teat. ~ . - . '~ , : .
. ;:: yr.':w: ~.<;:': ~ ' , :' ... .: .: _ ; . : . . . .. .°' ~ ~ . ..
'. ~ . '..? ~ ' .. . ~ ~ ~. , . : ~ . '.
. . .._ . .
;,. .. ' .;. . ~ . :. : ,x :. :. .~ ~~ .~.'.~:
'~:::y'';=~..:"..,~ ,;~, ~ : ~ .. ~ . , . ~ , ~ ;. .:,.~ , ., :~~ .. ...., .~
.. ~' . ~..~ :" v .'.:r.;.
. . : , ~ ' ~ ; ~.. . ..: v' v'w ~" . '~ ~ w:w ~: :.''..'.-:.::~,: t:
:.:._,::;',v:
w "::: . ~. ° w ; . ~ . : .y, .., . ,..:~' . ;;.~,..:,:;:.,.~;;y_ ;..:

'G. , ,,,:''; .'' ;',: .~:. '~ ' ., , ~ . . i ' ' :'~ .' ~~ ;,. , , , ~, . :. .:
~ k u;, :' ,~' ~ .'' ' ~ . - ~ ~ , , ~'~ .~ ' ~ . '~', '.» :z! ~=. t ~ :~' ' . , , . . ~ . -~~,~ ,' n of s~miiar 's sums stuff me~hn ~ ~ ~ gee ~.5. pa'oenct .
':' 0485 For a gtto . . . : . , . .
Appiic~on No. 0914~o,S93, which ise~gres~ly incorporated herein by rai ' 'b~ ~
-i~l~o ' . .
- ~ , ~ufierein are She rrie~~s and sysidescribed in U.B. patent Los. 5,9:'1 "5t)9; ' ~ ~ . ~ . . .
.~ ' :5,98,5,14; 5;984,8&'7;:4,464,166; 4,4ZR,744; 4,398,906; 4,3~1,9I9;
PC~y:~Iit~ini~':Noa. ~. . ~ , . . . .
:. ~~, v" . . . . . , .. . 1 . ~~WO~ 9~I36~634; ~d~ WiJ.9~'~I36581, alI ofwlzich are ecxtirely axirly ic~coifor~ed.he~ein'by : . .
:. x.. ~ .,'~t, ~ ' . . . ; , .. ' : .~ . , . ..
.. : . . - . -. ,~ ~ ~ ;. . ~._:' a.. ' :, ~~ ~ e~ecxive aunt of lift thallt is deliver to biolo~i~~l fl~iid~ ~iuaybe y ~ .' :~. ,.
.::.dined using the at~ethods ~d ~sys d~crib~d m U. S: PrTo. :6,~~9,5g4~
v4fiiah ~s - ' ... .' ; . : ' .- .~ ' .
... ~ ~t~e~Y e.~pressly iriaorgorrated din by rice. ic~deed, the ~appli~atio~i~of BCP' to the . ~ - ' . ~
':(':::.- ' ' , ..; . .~ . ~ . ~ ,~
. '-, , various ~'diss. described herein may requite ~ adju~ofth~e aoioimt of li~tt ane~°gy to ~ ~ . .'. ~ - .. .
' . y" =P; ~ . » , g ; , . . ~ ' , : ~. ~~'~'rl~ol.'~, ~8 g~10~01.'haln~ auBBd ~! t~ pr~C~SB ~~ r~10'V~d . -- . . .s . . . ;'. . ; . ~ 1 ° :
. ', : p~ ~ ~ ~e biological quid to the ga~ient. For Vila, l~ai~ ~ -' ' ;
~.. ~ny~,;1 . '.:. ,~ : . .. . . .: , . , . , . , . . . .. '~
~ yUVAtDEX~). utitfzed in~the ECP prams. Methoxsalcn bolon~ io a grc~p~af oarnpou~ka ~; .~
a: '. ~ '. ~w~ as psoxaleos. '.The ~cposW a to mathoxsaisn or odler p~oralens:mayy a i~.~rable 'A ': : ~, . . ~ . . - , ~ ' ' .:a ::: : . ' : : aff~e ~o~x the s~ubj.te~pi~t, or donor such as phototoxicily ox other toga .~. . . . ~
-. . ~ ~ .:.associated wish paoi~al~t and their daubiora products: ~Thor~ora, tbe..~~aie~, ~ ' ' .~'d~v~iav~,.:orpsoralea decomposidon products th$t may x~naia.#~~tiie~biolo~ical:fhu'd~m~y ~~. ~. ~ .., . ..:,. :. ' , ..
':~'be ~etriovW a~e,~'tT'~.eapasure. ~1 gi~ocesg fox the ra~t~ovat ofpstei~
bicil~gic~at fftdds is ~, ., , . - ~ ~ . . ~ . . ; 1 .:~ , . ;.y ' . ;~. : _ . .
: abed m iJ g.' JPa~t No. 6,228;995, which is entnrely expreeas y ~ , .rpai~ed , by ., . ..
. , ' ~ ~ ~ . ~ ~ ~~ ~: ~ ,. ; , ' .' ~, ~ _ . ~ .
k , . , . , 4' . ... ' .. , ' ~.~:.~f~:' . ~ ~ ~ ' ~' ~~ ' ' ' ~ ~ ~ t ~ ., . ..
.;...,-,:~:~:'.~= '::..'.,. .' ;. ;~ ; . . C... Ce~nBowl - . . . . . ~'.~~
.:~~ .:, y '; . . \ ~_., ~: ~;~~ ~,;.~ ;.:. .:, .,vtv: .. ~ ' ~ . , . ~ . . ~ " .~ :i . , ...
. (per :Tn a. speca~c' embodim~st, the p~re~t invention relates t~ me~lh~d~
:~d app~uts ~ : . ' . _ .
t= _ : . ' ' , ' ~ ~, ~. ' ' . . ~ ' ;
.. ~ " 'f . . :. s~ ~ca~.tluid con~ons, such a:, fox e~mple, the oo~pan~s, of a biblqg3cal. fluid by ~~ . , . ' : .
~ . city or weight. ~~olo~al flruds ancompae~ f~tuds i~t coisa;: ~is3:~; or are used ~; '; ~ , .. .
~,~. ~ ~ . .
. .ordWvered .to living lorrisms. lniieed, biological tlulds mey comprise blod~y fluids and' . . ~ . . .
~' ~ , ~;,~~~ such.a~ blood ceps, plasma, and other flutida'tba# ~nt~irjae biological ~ ~ . ' . ' . ~ ~ ..' ,com~ono~~s, ii~cluti~ living org~#s~s such as bacteriay cetls,.~or o~ei' a'~litisic~eor~one~: ~
. .:, - : . . . . . ;~ .
', : . . - . v . ~ ~ ~iolo,~ical flwids m~iy also comprised whale ~rtood- or ~pecifia whsle ~ti~oad'cot:, ~ , ~ ~ ~ ..
. . ::> . ~ ~' . . .:. ~l~ding red blood cells, plsbelets, white blood cells, and precur~ot cells. 'In particular, it . .4 ~- . , v m~y.be° desirable to remove blood ~'oan a patio for '~re.si~ch~:~ ~le; ~. v :; cereal ~. It is to b~ undecs~too$,-however, that'dze.pi~sent'inverition ~~
~ . ~ ~ y ',. .
. .'.~ ~ . . . ' :~;' ' .
'y w,, , . ~- ~. . ~ ~ . ..:' ~ ,'. ~. ~, ',. ; . ;' ::. ,~.:'.
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'.':..; -,' , ,; ~'.' N., .~,''.. ~ ~ ' ' .. . . . , , ~ . ", .,..', .:i , ' , ., .~' r,.;. .. ; ;.~; ;.., :;;.
_ ...,. :, ,, ...:, . . . ~. , ., .. . . . . . . . :- ~ ,,.'y y ~., '.: . :
:;' . .: ~.,.:

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~ad~t~e to use with various c~tcif~gcl pmcessia~ apgatnLus, andfbo ~p~ci~c I~ ' .

3 ~ . ~ ' . ~ ~ : ..y , .
L ~ :'~ive4 iris .merely for i~ilustrstive purposes. r uses for tlu3 ~ep~rralioa~:~ecl~ai~ques~~rd' '~

' ' , . , , ; .. .
,~ may include other xriedical preoce~ses sorb as dialysis, ~i~r,;platelet ~ ~ , . : .

. ' son.~d removal, ~aad separa~oa~ and removal of other sgea~c ells: ~
.~dditicm~lly, ~~e . . . ~ . . ., .

. . include a:~ ~widc waristy of : ' . : . . , , . .
~ ~;~ir.iuvion may. be used to 'sepaEate other type of fluids that .

.:> ~edicat uses, such as, ~'or 1~~ oil.and Quid ~n~po,sopar~tion.~ :A11 cou~o~e~
'- ~ v ' : , y '.
F .

~v .
' ~ :used the present iuverriian should not sdva3sely sf~ectbiologies~l ~ui~s ar~ie~es hem. ~ .

:.. .
~ ~' le:~vr.dieir.yuses, ei~c~ ~ those described hit a~cl r'b~ofauy ' . ~ . ..
. . . .
. :~
:
:
' ' " . : .:
.
: .
:
.
. suitnbh rneo'ble. with uses described ha'e~n including, but ia~ot limited ts~. gig, ~ . ' ~

~. , .
a; r ~ : suc~h:a~ polycsrbot~e,. y1 mett~aci~ate, sty~'ea~e-ecrylonitrlle;
. ~tc, s~rren~. ~ . .~ :. . .
~.
~

, .:,:. . . , .: . : . . . ; : . ,. . . . . .
: ' . ' . ;. ~: ~crslo, ~nitrile or arny oti~r' plastic. Vie pof th~ prasesit imve~xtioit ;see. ii~ics't~ ba be . ~ . -. ~ ;
~
.

:. ;,F.
~' ..v ~ ~ ' . :
' ' I~1. ,~~~tachdd: ~ orm'afl~aid ti~lit seal aay appropriaxte.conventioitaty '~ ajoi~tiag ~'~ -; together and ' ' . _ -.,1.
. : .,. : .:. , . ;: . . . . . . ' : . , .. ' . .
,:'. ~ . 'N,,the ps~ts.ma3~ be used i~lt~dfn~ but not limited to, adlu~ives,.
~ uiE wel~or Rlr . .
. .. -,',..,,, ~
~

~ ':N~~~';",..' y"' ;<' :~ ' , .~ . : ~ .w : , /,i. 'i: ' . ' fi.;e~':?iV,, , . . , . , '. . ' = .
, ' . , ." , , , i w ,: ~t'!~'.I~e present inve~ion bas several uclvantages over centrifuges ~ use ~onv~ ~: ' . .

. ' . . , ' ~ bawl !11'f~l~ Y~t~I.R~ ~'f~~ 3ySt~111~.9.0I1~1111et'pOrt the MOWS .
' ' ' f ~!

: 11.~ . , . . , :
. ' . . : , ,a .
. ..
blood ta cc~e itc~a the bowl aad one outlet port that allows ~ ~d buffj~
coat to~ . , .
whale .

,. ' .
~ . .
~ ~ :'~flOTil~ ptlk. ,~Vlllg Only tW0 t~'1B VOlurll8 IDS btl~r' Cast t118t .. ~8n b~ Cd~le. per ; ' , ~ ' s 1 ' ":._'". ~t~ b~o~vl to ~. ' ' ' . ' ', with whole blood; 2) ~pin8 'i~avolves ~lli~t'tu! bowl 1; ~;
cyete<..~a~ch cycle ~

. .
;yy,:v~~ , '.: . , ' ' .
;
3.) colre, bu~.'oost for ~ ~ ' ' , ~ ~~ whoie~bloc~ imo 1 coat, sisd r~ blo~l celts;
,";~~
' ~

: ; ;~
~. !
, ;Yi', i : . , . .
':3 , ~ . . .. . , , , ..'~ 4 bri~ag the bowl to rest; arid 5) rn~ collpl~ma apki red'bhood cells.
. . - . .
. . , , .. .
' ..

, .i,, ' =' .
~ :X. . , , ' a ' , w~ . ;. . . .. . ~ , . . .
v.. : ; .:y~y.coat co3lectron method tttay be d>a~cten~d as ~t'".blita~'',a~
' ti~ewolu~~ . ' .
...
~

, .
:; .,:1,.
.: . : , . , . .;~~. : . of busy .coat r~uire~ far izra:diati~n :treatment cmn only be ~aaIlel '' ~ ~' ~ ~yd,~. o'f ~ '.
. . ; . . , . .' .., . , ,~

': ~:~ . . . . . . ' .
. ~ ~ ~ ~ . ~:coat:rolle~on.' The li~it~d volume of collected butl'y c~oatyec~
cyclere~uitsv.frozutlie' W
, : ~'bu~' ..
. . ~ :

- bllcread ceils~ ' ' . .
:~: Thus tbo ~ accu~Ia~d ~
~: ~
;; , ' ~
' :&~%!~ ried~bipod cells ro~sir~eil ,inside the bowl. . . , . ' , . , .

_ . .
~ :~ ttu~ aaa only be d:at the end of a bccoat collection cycle is pan itrt~ea~t linaitatioa. o~ . ' . ' , ' .
.
.

A..,..'...
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.
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' ' .

,,, . .
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;
;
coz~clu~ts that caa be ttsod.~ . .
~,' T~' ~v~d of t~ mstaut invention has three separate ~lui~ , . ;

. p._.,..;'.~;,.,:.
' ..
: , ;_. ~ uilet ~ .rt and two'.c~u'tlst pats. 'The additional fluid co~duits~
Blows foi~~ reduce:pat~t .

~iv;-'. , buC4at'x011e~atiot~ ~'OCess, ' , .~
tt't #ime try ha:v~ng co~iriuou~ Spb'~8 during ~e : .
~ ~
~

.. .
' :Y.r:~.~.~:
:: ~..
~;<~:;
~ , . treat . . ~ ' . . , red Ficod. cells; 2) ' ~ witlubut~hawir~g to stop spanning the ~owt for removal of eccum~u~sted , . . , , .
fQ ~~~ . ~
atsam; try b~avirtg collected reed, blood,ee3ls'r saud~ blood volume ~

, . ~~;.
. ~ . ~ . ~dnuausly, ttxese gakiei~s may be'more amaru~le to medical trea~en~.yre~aitir~g site use of '~ .

. .~ ~ ' .
.

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~':'~'~~..Y:~~,~''~:~ ''.~~y:. " : , : .. ' .' ~ . . ~ .'~. '-' _ . " ..~ ~.., . ,,~w~'.~.
' . , '.:~~.'~' '. ' ~ ' ~ , t~e'buff~ coat or ~ad~s thereof suchas ~xtracorpor~
photopheree'isv 3) b ~sopar~ti~~ ~ ~ ~
1'A",: : . . . . . ..
' ' ' ,'of d~ffet compo~n~ts ~.of fractaons of calls 'w~thm the bufiyy coax die to xhe~ dsed ' . . . ~ .
.'.~~t. .~ ~ . . . . J . . ~
or rotatian tithe and ~) the ability.to separax~ ~:ig~i density.i~ad blood ~Cet~ fictions ~ . ' .
. .P: ~ . , ~ . ' _ ~ ~ r . ~ , . . ~ . .. .
. ~com:whale :bl'ood. T"~s cen#i~ge bowl also provides the oppdr~u~,y foir re~ced~tr~ ' . .
:: yno ~o~ any s~edic~l pracaitu~ requiri~ bo~.coat fr, actions ~v be coll~
~3toax pacie~s . ~ ' ~
..; :? ::..~;:,;~;~~'=; :'., ~tt'eresubstantially of red blood cells such~~as exfir~ ~re$1~IPli ' . . : . '. .
. ~ ~ :,~00~:] . rI'o aabieve tire objects in accordaiare with the pulse ~of the prbednc ~i~von, as .' and broadly tlcscribad ~here~, FIG'S. 35 and 36 depict ~peeW ~ is :of the ~
: ' ~ . . . .
... , . _, , . . . . .
.: }.. .~ ''.' ~~:iav~nt;t~.. 'The:t d~pfcted in >?Ia: 3,5 00~ a cbawl. 301, ~
. . . ~ ..
. ." ~ .cc~~~asly B~;A, a 910A end stationary res~int 9i8A. 'T'~.
~i~rifuge:bowl ~iCA
. : ': is'~ii ~fluid cQ~cations iNith exte't~t conduit ~~tlA of~condui#
assembly 8~ltA. Lowe~° , ~ ~ '' ~. : ~ .
. ~ ~sleewe. ~tid ~B32A. (FrCi~. 4~r) of ooruWi~n sleeve 3400A is secured to bawl ~Oa~, Upper sleeve . , .
~~e~d' 8.31 cf cc~rnnectiot~ sleeve 50i~A is secured to~ extari~t conduit ~tlA,~con~ecHn,S'tt~ , , . ' . . ' .
s . ,.. .. :~ . .C:
. .. .~."conduitZOAtobowl ~0~ m~d~prov~ding fluid co~catioas~fror~~conduit ; ~
~ . .
. ; ~4~A. ,to .bowl 10A. ~ 'Ihe: i3edd c;arnnnmioations ~,abie~ fluid 800 to b~ .sWpplid~ ~to~h' . , . . ; . . .
. ,! . . . ' y,oonduit?,4A to.tha bowl itiA.Sy ibis fluid c;omm~ric~io';~, ey~ ; . . .
.<#~.:,.~ ': ': "~.~ . . , y~~~ oom~on~its 83A and B~O .to be removef $om bovv~ 1:OA. ~ ~ . . , . : ' .; . : . ~ ; .. . ' 'y . ~ .
:~duit ~~O~k. ,Bowl l0A and 910A acre adapted to be rotaxed acot~uad c~er airia I'1A.~ ' .
...'; r . :'v :;. ~°~ ' '~(~~. R~~B ~ FI~"'r. 36, bowl l0A ca~mptyses~
outer housuxg ItIOA,, co ._nnection sleeve ~ ~ .
~ . ~'. ~ :~iIO~A~,~top:cota.~t~,1~'ttom corc.Zlf~.~l, attd housi~g~ floor 1$OA.. t~.~,cvho,~ing iQQ~i may '~~ ~ ~y . . .
~~ ~ .. ~~W~ . ~ ~be ~clnd of any~stutabt~ 'biocom~at3ble naate~rial as previously des~ribecl'for ~.gbzpc~e ; . ~ . . .. . . .
~'v.~ ~~' ~~' ' ~:of the ~liistiation in~l~It~. 3& the.outer ~o~sii~g IODA is aons~uct~' ofclear~p~last~.c so thst , . ~ . . . . ' . ' .;cores .7~OOA.~apd ~01A aro visible there throw. Outeurho100.A: is:~ied'tv a.'. .~ ~ ~ ~. .
.... :. .. : . ' ' fog loclt~ br~wi ~~A~~into a rotational ~~' ~ ' ' : .; :floor i$Q~, vvin loin compriseg pio~ 15l1A g .
~:i~.'y; : ..w ; . ~ ~atsvic~;sneh as. rotatio~l device 90t~A: Bowl iAA is prebly simpli~ed'~ii~,con~tion and' - ~ , ~
' ~' is .eaayto ~iu~factu~e by folding or other )asawn m:~~.~p;~su~ tbsi' it a~ay ~ ~ ~ . , .
~ ~ be. d~stioeable ~o~r used for ~a limited number of tie, mdd i~ most pir~'e~r~bly c~pabio.c~ ~ ~ .. ~' ' ~ ~ cog about '123 m~ ~af d, sWfluid possibly being Prea~turi~e~.vn e. ' ~ .
.:.<>:::~.~:~ . : ' ~: . ., .. , . , . , . . .:~ ,, . ; _ ' ~: 'bo~i~cits, the voice capaai~y ofr tlzs bowl znay vary dep~di~ig itpoia hcalt'it of the Y '~R: ~~ i ~~. : J". ''~ , . . . . . ~
~ ~'int. end his or h~ ~a~lovtwable extracorporeai volume. 'Tla~e volume r~ipaci~y~ of the-bowi~ . ~ , , . . . .
,.~~:... .: _ : '.. :; .. ...
.~~' .may: also vmy ceding upon the 'use of the bowl or flee particular 'xifor which t: ~
~ . ,~ .
'.'v~' .: . : . . ;~: ~ , ~ , ~ . . ..
' ; ' .~t~ow~ iia utilized.' Additionally, to awogd con .ion of biological' fluids,. fir. exposure'of ' . .~ ~ .
. ~ ; ~ , ~ involved in.thd .pmc~ssing Operation to the fluids, the tt~stLr°op, ; ; 'ons are ~ v ~ ~ ~, . : . ' . . . ; .
~ . : ; ~ ~ ~ ~~. . . . : ; ~ ~ ~ ~ '. ~ ;~
~ , ':. '.,.t ...: ~.. : .~ ' ~ '.. ; ~ . . : ' , . ~ . ' :
. .~ . ~ . ~ ~ . . ~ ~ , . ~~ ' ... ' ': ' ~ , ...~.~~ t ",~ ~: ~ ,'"~ .' ~ "
~., ' ~ . . . ~ . ~ : . . ~ ~
:~..~f~~ ~~: i'~ . . : :.. .' ., . .. . . . ~ ~ , ~ ~'.. .~,~,. ~' ~ ~ . ,~
.~. ~, '': ~ :. . Y

,~~~ ~t: ; ? ~~ ::~~ ~. ; i , . : . , . . . . ~ . - ~ ~ . .,,' ' '. ' . '.,.
.' .. : .;',;;.
,:"' .,.. .. , a ., .;' , . . ~ .
.' 4i,d..l.-I . 4 , . . . ' .. '' '.s.. ,'.
=' . ; p~efbly carried out within a sealed flow sys#sm; possibly press ~
.urize~E, pr.'~I3' ~rnaed c~ .
.. ,, ...: . ..:, : , v ': ~ bie pl~tio or sbriilar ilaatErial wlfich can b~ disposed of after i u~. ~
~~' .: : . ~ . _ ,. .:; . . . , ,. , y ; .[Ot)9~;j A~s is~iil't~rated i~ I~IC3g. 36 ~d 3'1, the outarhous~g ltl~~ isaubsclty.conic~: . , .
..~: ~v7i~.~ an t~pper.lao~us~g .end llilA,~ ~kn outer Housing wall lxOA and ~
lows ~ou~~ end . , ~ ., :.
l~tlA.~ . Outer Iaousing 1o0~1 may be made of plasl~c.(such as those plastics:
[~sted previously) ,:., . ~ . , , .
.~~'or. auy other 'suitable m~~isl. . Upped housir~~ end lt.tlA has. a~e.outei su~aCe llaB; ,ice , . ' : ::~,11t1C and housing outlet °~OO,A pravida pad ~etw~n tad s.
:Preferably. ~ . y .
'tile ur:ho'using willalso have a r~c~ Il3~l.~'Arm~d aboat'th~ l~usi~g.~out~et . '~~e I~.' #~ou~iii outlet'ltl~A a~td neck 1'1~.~ ar~ sited to allow bbdy A:.of ti~a '~en ~leev~ _ . . .. , . .. .
_~ . ; . . > ~ ~ . . . ,.
'v3p4~1,to pass thrau~ii ~?vhile re~ini~g ieo~ f~az~e'~~tlA, which e~st~iids flr~m a body 830 . ' .a~ fln sleeve SODA, Ioa or~~ badt of the present~in~i~n vn'o-ii~,g.'191A may ,y . : : ~ , ~ : ,.a. . , .
f ~ '~ ~ ~: .;; . .
:'b~'betrovey #~e slave flsr~gci; ~90A ~d xr~ne~ surface ii~~ of.the: .b~B ~d laOA y , : . .
. ..
:...;x.: :;. ; ..
I.~,~o:eu~s.' . ~ ~ : d did ' . ~aal ~is pmvide~. In ~ alternari've amibodirn~'t~~~'t~e~resent inv~.an ; . , ~>
,; =y;.~,: ";~ ~vr ~ ~~ .~ ~ ~lu~.t~'~ted ire ~C~ 53, a.second sieeve~
~lange'~908 eds,~om the~body ~~3A, of com~ectfon~ .. . . ., .
~. ,~.~8VC .~1~~ dl~ to. t~8 S~~eVI~ ~~A. ~~1 B~e~VB
$~.°'~~;#~,~;'~9(~8.. . , ., . , . . , ' .:; ,: ; .1. ,:. . . : ,,. ~ ~ ~t within nbck 115A srad ~teta~ o~ring'191A
thax~bet~~. . A a~d .tx~c seal is.~ , . . :: F~~d~ in this embtt.by ~e oArirag contacting body g30A andazti~:1'It~
of~.. .. . . .
. ~:;.j:. : r: ... . ; . . , .v the housin8~ end lltlA ~adjaGent to t~ n115A Hfawever, cormection: ~,~ye ~OOA~ cue, be ..~ :, ~: .
. < sec , . ~ .to bovi~i iQA: by sny suitable 'means, ~n tiding for exainph, a, lip, rove; or tight ~t .. ' .y;. : t.~ . , ~ : . .,,. ~ , , ya:,ive with ~i co~p4ns~rt of bowls 14A. 2t~ outer hou~ing'wa~ joun~s:;t~
upper housing . _ .
~. : . ~. ~ . ~ : .
w ~ ., d~llUA and' lover Housing end 190A. Lniwer Housing anti l9IlA ~s atta'to a housiy ~ .
. ,.,;: , v . ,.
.. , i4 :. _ ;': ~,80A. 0~ greater' di~t~t~'. tbaa upper end llflA. Housing ~fi00r 1.:SOAy adapted ~o auate. . .
. . ..
w[th the ~lowec k~usitig end I9gA ~c#. provide a Iluid tint ~s~l, tevvith. .
~irry con~ent3onal ,:...; , . . : . , . :, ...: : .': . .
. .: ..; , : w; ~~. means.m~ be used td;s~cx~re the lower i~ou~it~ end 190A to t3~ houflflor' 1SOA9 . . . . , .
~, :: ~c~u8i~g but not.limited ts~,~adhesiv~s, ultt~so~ic welding or'RF,~?veldu~.;:..~°'as~ng floor, ' .
;.
l8QAatr~y hare ac~.andeion 1851: that is use to collect dc~s~.flui~
BlQ,.diameter o~~ . .
' 100A incre~es from tipper housi~ arid 110A do Iov~a hous~g end 190A. . . , outs: ~. . . . : . . . . : ; . . ~ . .
[(1~2~ Outer Iwwsing IOOA. is adapts to, mtatabiy connect to a ~ot~odat ~Itvice '900 (FIC: . y . ., .
. 35~,~scuztr~as for epie, ~a i~ar drive sysie~ yr a rotting brao~ 91Q.
'TYia,ble ~:' : . : . . , . , . : ' . ~a~~,~ ~or~ pie, be a bearing that allows ,free rotation o~bow'~ itlA.
~4i~r ~ ..
w hoi~i~ ilbA pref8rably has a locicittg mecharcisra. 'fhe lo~c'ing ~ ' . '~i~
n~a~y be, arse or' , ~ . ~ .. . . . . .
:. :, ;;::. '. , . ~ ~ mtru~io~ 150A~ deal d to with correepancl~g i~a , ~ . , ~.v ;°~.:~.~~::: ,.,:1:.~°r~.p , ; ., . .. . . ,: . .:~ w ~ . .
:. .. ;,: '.., :;.
w. <.:..',. .~;~ ...,. y. ': ., :.. . . , , , . . ; y' 'y , ..: <. ~ ~ ~ .
:.., :w . ~..,.y ::
,... _y . :.: ; ',., ;: . 2~ ~ . . . : :., , . : , ::',;:~;;::':...,,~,;.,'.:':.: y , : .' ,: ., . , ;, . .:.v.,... ~ ;, : :y. .
,. .,::,y ';.y.,,,~::~....,.
:, i' .. :. ,. . . .. . .. . . . . . .. . . . .. .. . . . ~ . . . . . . :. :.:
. :. . :...i ... . . . .. . ... . .. . : :: ::.
:......;~.:....::.::>: . ..;. ..: .: . : . ,. . ; .. . , . . ... . ., ~
. ~' ;~;,. i.°°..~.: ~ . . :
.,ii . : . , , ~ , . ~ ~ . f ~ -~~ ' ' ' ~ ~ . ~ ~~~. ~ . ' ~r~ ~ .~~.~::~:ir .. '. , ': .~,'~ . :::
'~... ~4~~,i,'-~ .':.~ ~~. .f ' - ' .;_ . . ,. ~ .' ~ . ' , ' .1 ~. ~ ,~. , ~
~ ' . , , : . .~, or ~~, other suitable intacconnect or lockbig m~chaui~n ai ~u~ivatent known. in ~#e ~ ' ~ . ~ ' ~ . .. , ;.~.~~ .. : . . . ,.. .,. . . .::~:,~ . . ~
a~r#.: Tf~e~lg mecl~ism may also-comprise ~i lcey stot~160. (ixtG~ Sl). ~ ' ~
~ .
:.',,~~.'y ..~. . :; :. . : . ~ , . . . . ' . , ' ° ~ ~ .~0093j' ReF~rin;,S to FI~'x 39; outer i~ousi~ 10QA snd ttte bass iSDA :d~finr .fit irrt~rio~r ' ~ , ' . ~
. ~ ~ , ~ : v=..wolucr~'11.OA is wbichi~ores ~A and ~OIA w~l frt when bowl laA
is asseiubled, Whey ~ : .
.., s~ : . ~ . .
. l,:vfugy ~a~embled, cores 2~A mid ~1~1 are fi~liy wild interior vole~re''fi~k of outer ' ~ , .; ~. . ..
. ~'~' ~ r ~ ';,~ rousing i~A, oc~yyutg a Qo~al volume of i~nio~ voiwt~e 91~OA
aiiaatt ~tis ~ilA. , ~ ~ ~ ~ . . . '.
:".~~.
...'~ . Illg t0 ~~rl.~~, ~' ~tlt~ 44,1~'tfip ~rB ~~. 8ild~b0~~oItl Cnr~;,'~~.A
~~1'8, , . ~ ' ~ ~. ~solist~itietly co~cal and respectively t~ve~~up~pcr core e~s 2t13~A,.?.EI~A; outer core, walls ~ . ~ ~ . . ~. ~ . ~ .
:~~O~k; ~11.A~; sad lows ooro~ends ~9~'~h, Z9~A. 'fha scores 2DOA, ~2~lA.occy ~coaoda~ v: ~ : .
. .vol~m~s~of itnerioi u4luttie ~10A of'bowl 1,~A and tbrmin~
seParatior~,voluz?,~aA~betwee~ ~ ~
_.~~ ':. : ... ,:. '; _ , ~,~~'~d,ottter well 210A of'bo~ core ~tt4A and outiar~w7alt ~llA ~ndlowe~ cc~v ~ ~ .
., , : ~ .'end ~9i~A~ of bottom rote ~2D1A end oar h~i~si~ 1UOA, Se~~atinz~
vclsi~rie2~QA is~ fast , . , ~ . , :~ . ~ , . . . ~ : . ~
~': v. ~~pa~oe of i~rior vohune'~laA tl~t is ~etvv~n ca~~~t~~OA ac~d~~OIA'~d or hag iQO~~ ~ , , :. [OD951 ~ As .d~sicted its Isis 40 ! 41 tag oars 2vtDA comprises upper ~ceuadyA and a . ~
-~..<w,~~ "~~ :1 v,:'.~4w~ fore ~95A that ere joi~d by outs comwatl ~10~. The o~ite~r ~wall'~~:OA
.>..'< _ . a r . . ~ , ' °~ ~ ~yaviag~:outersa:2108 end znr~er wall surface ~tQC ~d s lowexedge~lOD.'f~ . , .. - .
... ~ ~. ~ ' .:'~ ~ ~. , . . ;. ~ ., , ~ ' , ~ ..
. : :;.,, ' ; .. .~ fir. of topcore ZObA preferably increases from ups ~c~~.end ?;SSA ~a lawe~c core eud~ ', :. . .~
~ ~ ''~ ~ 'Wv'~ ..;~~. tar corg.e~nd 106A, also a~r~prises ~ outer su~acs and au °:t surface - ° :,::;,~ ° ~ . ~, C.~~,.C~mraity lac~~t0d about axis aatd e~ct~i~ per~sncFøtd~ly~~dm the uøpe~ , ~ .: ' ~ . . .
~:::.: ~~ :': :'::v:~:' ~~ .: ~ -~~ ~ ~ ~ v458~ns~ lum~t.con~toa 4glA. Lumen cantor ~481A ~b~s~ a'1t~ .,48~A ~d , .. : ., ~ ' ~ .~:. , ~ : ':
. .:~';.:.~ .~'~'~~~1 ~ vwallaur~ce 4~28:''T sniPa~4lt~Al~two passages 303 ~i13Z5~ t~st~~provide~fluid ' ~ ~ ~ ~ .
' :V'',' : :X.,:S.;: t ~ ~ ~i . ~ .
' v:. ~. ~.canicat~o~ ~ the upper sire e~ ~Q6A with 'bowl ~1~41aA'and first ~
. ' ' ., ;:;.:~,, ;;,' v;:~ : : . . . : . ~ .
,~.";:.: . . . . . . . .
. - ;,r:;;, . ::.'.: .v~~ ~': ~.:'buw~ 1 ~424A respectively. Second bowl ohi 41~A is a cou~id~t aE.'has a,' conduit' ~
';.:: _:.~ ..;: .. ~~: . . ."
.. . . .... ~. . . , . . . .
~..~'..... . ._.: . ~ ~ . . ., a . ~ , : . ~ ~ . .
...w$11';3~~A that a~teyperpeudicularly from the u~ s~oa 481C of lco~ocl~r ~
.. . ' .
.:i-;;r. ~~.. ~ ~ ;.. ~ ~ : . .~ , ~ . '~ ~~~~N. ' ~ . ' ~ ~ . ;~., ~~', ~' , . y, ~ . ~ ;, ~~: . ~ ' : ~
.. a '' ~. ;[t1496~. ~ ~howu on F~C~S. 398, 39A sad 40; sooond bawl cba~l ~Ii,~ ,~~u'id; ~ . ' . ~ , ~ v , . ;
..: .Caca~oa With~~condtut c~r»el;'6tlA ~ cori$~t 321A~battln"g a ~r8t end' ' ' . . .
a:~ ;:~ :. : . , _ ..
' . . , , ';' aad a~'~ecorid end 3~iC that is aclapteii to ~t into passa,Se 323,1,1 afiu~esa co~tnbctor 4S~,A. Vin' . ,, . , .
~a ~ . . . . . . . . . ;. ~ . . . ;' , .~. .. -, ~ ': :on co~it bet ~60,t! of eotteznel conduit ZtI~A.Wis Qi~ir#~~'c~i~. ~u~on~ with bowl;
~~ ~ ~:.~. ch~~l dlOA"' First.bawl~cha~nel 4?~A is a ~~ ~t tilt a chami~al wall 4'~~.A'~~ ~ ~ . . ~~
.,. . , . .
't . ~ '~': ~ " ~ ,. . ~ ~ , s .1.: ~~.;~ ' ~ . ~ . . . -~::. '~= .. :<' : :: I: ~.t~t:e~ auba~islly Per.icu~'1Y fram.ianer surface 4S1C of tbeyr coot . ~ ~ . . ' :fr~:~'~.' ~ . . ' .. ~ ; ~ ~ : . ~~: . . ~ , ..
_. ~f y shovvn~ in IFIe#5. ~3gA,.39$, and ~40, ~ra~ bowl chaamel ~aoA ~uid~ ~
, ' , ~ . .
. ~.~ :: .~ ' < :: cornrauaic~ttion with ~ronc~uit cheeme~ '~oA of e~ctI co~it 2o~i~t'~rougti~hollo~ cyliud~ ~ ~ ~ ' . . ~ .. ' ~
:: ,.'..~ :' .:: :; : : ' . ~ . ~ ,;~ : : _. '~ , . ~ , an ~ . ~ . ~ , ~: ; .
~ : . ~ . . ; ~: ~. . "... ; :;;::, ;.:~ , ~ ' ~. . . , . ' ~ ~ ~. '~~. ~ ~ . , ~ , .. ~ ~~
:.,x,;~~'...1"';: .l...i~ ,. .: .. ; ~ ., . ; . ' .., '.,;. ~. :'~..~~. ,~~ ~~
._.- y~
.', , .. ~ ~ , ~ . : ~~.;;s, ~...: ~ ,~ w.', ~'. ; ~ ; .~.,,'; , ',"~:'..

~ ' ' ' ; ..~':'~,.~.;-, : . : . . . . , . . . ' . , ., .,, ;"~ . ... a .' . ."
, :
f , , . , ~
~ .. .~.o: , ~.
~ ~ .~ , .'~, '. ~: r . , c..,. , .: , ..
. . , . .
.

t: . . . ~ 1 , ~... , . .,... ;r . ;:..
. 3aZA navi~g ~, Sist edct ~32~s gad a seco~td .end 3aaC adapted to f~ opeo3t~s top ~. ~ ~ .
. .
. .

r ., . . .-482A,. ,As ~as ialusttat~d in oz~ee e~bod~rnent :;: . o~the presea~t~iitveotim~, seccbi~wvl,yl v ; .
v. .. .. ' ... . . . .
:

:410A"is i~isposed within first bowl ch~nel ~4~t1,~,,, In an ei~~ati~e e~bocti~eat of tire ' ~, ~ ~ ..

. ~ , ' ~'Pinv~~iorr ills in FiG. ~3, candu~t wait 328,A, v may bd c.~icso~'upp~r~pact ~

:,: .
, : . 3~F ,and Iower parx 3?,SG arid be fused with _ chaos walls 40iA end :~02~1~ . ' . ; , , . ..
,.',,_.' . , ' ' . . . . ~ a ' .
. .s , - . ., ' ~ .[vo97j. ~T~p. ~ .48~A also has indtioa 483A whictx, provides ~(ida' ~~catian~ ~ . ' .
. . .
~

'~ "~
' ~ . .with chamber ?BOA: ~ sssembl~ci,. cl~m~er ?40A
i~ deed b~lu.:inou~ng~recess .
~

~ ;
v : . .
~ : : , ~ . . : : : .. . :
: l~lA less ~e vole occupied try hollow cylinder 321, and,3~A ~3n the?aorio.n .
.
' w ' . . . .
;.. :
~, _ .~:
, . ~ w . '~~,of r~ormection sXeeve StIOA aia~d Iume~ canreectar 481A.. ~ 'bv ~~O~i has ~~haid. , .

~. r .
;$ . . . , .. , ~ .:.
n~ck :: vcacatan with conduit cal;??D,A. and.tvith separation v~tr,~e ~~A;.z~r _ . _ ~ .

~.115~'~ indeioo 483A. This indem~on A forms a p~way'foi~ the. renn~tal. .' : ' . .

... , . ~of seao~ s~epersted fluid aompone~S~O ~rou,~ bawl . eh~bear ?4D24. . Opttoneily prey , .
.
-, : ; .~
.

' . .
. .
: : .
. "
,:on tt~e' amar. surface a0.~B aro a plurality of spa~c~O~A which. end Jfxo '~i the ~oixtei sur~Ce . . _ . . .
. ~

~ '. . .. ' . . : .
. . ' ~ a~dvcon#acx She inner. siu~f~e ~110C o~'the appear hoosia8.~d;1~QA. to ~eu~~~ud .

oom~ t$.e ~~tion volume aa4A. ~d 'the .p~s~ev:fan~ii by tba '...._;,/,, y,~~.y~
c,';7.:, ; ' ~ ~ ' ~
' .,,.

" .
' ~~lttst~ed is ~It'~S, 53, Sd s55, coriiduita 3al:~A.
and "'. . ' ' .
,~~ :In ~ a~tvie . .
' 3~fArnay bye sd~.t~ ap~i~gs 3Z5D and 3038 ~r the top sure 48~x~ ~qf the irun~

' . y ~F 481A. ..nary, it~delitations ~83~A may form . a plurality ~ih~t'he'Iume~i .

' .:.aomu~ctox~4i3lA and6e adapted to form~cbe~ 940s wb~va co~.to cticm ~leeve'~
I

. ~ SppA-or,5~8. Cliembar 74tlH is adapted to have ' ' one or mere sea' ?A tbat.aao mate y .

.

.y , , . .
.;: :~: ; ..
. 833A.yuods e~ct~861. of .
. ibe r~sh~ cud B~A, of the ion sleeve SQOA. (m~ie.end ~ . yvit~

~ . ..
: .r , . . . . . . . '4 a stsevn,~DOA. to ; :.. ' ; ~~. conduit ?~oA~. Te facilitate the cone~fi ' ' . arioa of t'W cot~ec~i4 . . , .
: : ~
:

a F~ . . . I~ may ~e ' .
. ;''t~lw~irco~ector. ~lA the shape of the male arid 853A andybei fi~

' ,.' nor~yicst or es'is illusttire FICzS 5~; 54 '6c'pro'vided . , ' ' ~ 55 a gale 8r55A~m~y , s:
~
.

- : .~ ~ from ~e top sce of the,~Ium~'eiotor 48i~9i tada~o F~'wi~n .~ ~
. andis ad ~.

, . ... . . , .
, ._ ~
, . : ., .~~88?A of'tbe ' . .
. -' ' ' ~ <'..,.slneeve ' ' fl ' ' ,:
W
~.

. ~ . , .. . . 1 :: . . .
~~. , . , .
,.:;1"~ . upper plate ~.99~A, ':: ~ . . , ': I~1 ~g~n~:bac~ta~F.~ ~ov~e~ core end ~SA.co~piises~an ' . _ .
. y . ~s and rx~
'. .,;~. ; .. ~~~ ~ ~.' ~ bQttort~ s~u~ce, xg'9A, mid , ~ ' . . ' ~ ~
.:.
~: .~'.,an ed,8e,Z9g~ . . ' t~t ; .
:

.. iovve~ ~e 2~~D of the outer txyre wall alO,A: ~'~ie299 of the ' , , .
' ~; duct ~o~ct' with .. . . . . . .

. , ,Z~9A ~s ~d ed io be 'oined with lower ed~a re wail ~l~A anf .
' ~10I~ of ontet ~' . : ' ~PP~' p .
.
a _. , . .
. : . , . , ~ a9l~A of , ' .quid ti set t3~rewltlt. lE~,tend~ perpendicuhrly , &c~~ the top ~
forr~:a . I~ . ~

. . .~ : , .i. . . , , ~~8t$''~,t~~'IS',~ C18~ wall ~~~A, ~Vln~ ~~7r _.
..; . 8IT 11~'?p~' ~d ~ ~11d~ ~ ~oW~" e~ ~ - . ' n~

~

.;:,, ' . . ~ ~ ~~' .
'"
; .. ,., , ~ ~~ ~ ;, . . : ;., '. ~ ~ . .
.. , : , : ;
~

; ,, , . . . .:
. , .
".~ r ..
.~. ;
.' ~ ~ ~ . ~ '.' W , ; :
. ~ .: .
.
.
.
, ~.. .
v ,.. .~ .: ,.. . . , .p~ ~. ' . . .. '..,~ . . . ,. .. .. .
.. :. . . . . . . . . : . . ,. . , .. ,..
.

~- ~,' ' .. :, ; ' ~.' ~ ~~ ~ ~ ... . .' ., , ': ~ ~
t : ~ . . , . . , ~ ' , ~ .~~ . . ";,. .
'. ,..v y ~,,. y~ ; ~ . . . . , .:. ~. . - ".. _ : , ' .:

surrounds opening ~03A~, which via sutbstautially in the of ~sr ~Iat~ Z99A: A
,' . . , . ~ . ' . ~ .. . .: . ~~b~r of fins 40~A,att~ched to the ou~iae surface of d~aanol~r~~v4o?,~,,'tope . : ~9sA,. suppar~ i,~ wall 4oaA. °~'he channel ~ratl ~oaA~is ed~taa i~
.:~'~, to with r~annoi . ~ : : . . ~ . : .::
~ :. ~w~I ~IOiA ~rmittg a,f~~aid tight s~~~arid prorriding iurnar~ 400A. ' First''bo~I. cl~nel ~~A is ~ ~
. :~. - .; ~
:' '... ~. ~ ~ ~ ~ iii ~li~id. CoWith conduit cb~nnel 'rSOA of ell arndiiit ~0~'througlz'aond~ait: '. , . r . : . .
. ,. ~: .; , - : : . ~
. ~ ~ ' ~,~~,~, pp~~ ~A provides tlaid oornmunications from lui~ct 4b0A.~o sepsrarion. y ~ ~ . '. , .
~. 5: : ,.t . : , . . : .~ ',.. . . . ' ~, _,..." _ ,, : ~ .~ .' , : ~ yolu~s 22oA.as with be ~ disc~ssad. First bowl cl~u~el ~~,~,.at~aisurrauads ~gcon~d ' .
41tlA. . : v ~ . ' w ; . v. . ': ~ .' v~ . w ' v v':- : ~ . ..
~ ~to Fi es 43 X38 a~xt 4~ bottom ?.(ilt;A ~.'' ~ ' rises an . L. .. ~1. R~ . ~' ~ . . ~ . .. P . , uPp ' . ~ ~ ; ..
~ .:' ,.~ _~ I. , , v~ t~~'e ~e~ Z06A, a Qatar core wall ~I ~A and a Iower coax ~xrd. ~~A: .1'"~ a~tez' iCor~s walk , ~ ~ ~ .
' .i~~. ' . . ., ~
~ ~ ~ ~'.~ Z~1.,~ having ~ outer' su~Ce Z1IE; an i~oa~,~r Wall 211C aid lor.~er edgy ~~~D. 'fhe~~d~me~r . . ' ' .~ . v: of~b~ttorri c~ro aalA ~ re~tebl itac~ases'from a er carp end 206A
to~lowdr oore~mid~296A. . ' .' . . ~
~ ,.. . , .,P .Y , P.I~. .~ . .. . ~ .
~f: :. v . ' : Hot04m core 20~iA also has a top sutface 3~9A ~d a bottom sur~e:~tlfBTop surfhce , .. ~ ' '.
': 3~9A has, ~ iud~ tgGA ably ta113' circular) suibstatytial i~ tbp cof t6~ ~
. , surd 3n9A of the u~ppe~ core end ~06A. 'l~ indention L86A has ~ tippet stufaoe 1' . .
~:,' ' ; . . . . . . .~ . . ~ ..
and ~n .inner' surface ~1~6C. The upper s~trface.1868, of the inddcan .~,S~A, has: therein an. v .
~rnng wlt~ch ~ tbro 1860. ~ . ~. . ~
. .~. ,~ ~ , . . ', : ~. , v:: '. op~ y. . ~ ~. 324D ' . . ~ ids , t~h to the ianat su~r~ace~ ', , . ' ~i gin: ~ ~~_ ;~ 've~ ~; . ~ 1 y . :, , ., ... " ;
, ~ . ~ . t of t~ pent invention illustrated in FZC~ ~3, the upper. surface 186B, ~may also . . : ., .
.. ~ yI;~:C.. ~ ,) 1'. ~ ~. ~ . ~ .:'~ . ~ ' . .
:. ~~,.~ ' ' ~. .haye a.rss a~86p adapted to xeooive as oari~ axed forna a fluid. type.se~ e~and'ths Iowe~t ~. ~ . .. . ' ~
. ~ ~ ~ ~ . ~of3 ,~'''B of tui~t wall'3~SA. Exuding Pa~Pmdicolarly $om:itsnet~~' 1860 ' . .
~
. ~ ~ :. a~cou~d ssi~ opening 3ZAD is conduit Wal1324A having.a disttal ~nd~~?i~B.~ :Eh~ tk~~tcp ~surFace .
. .~:;,: ~; . ~ . 3~9,p1'uling fioai~the~iundtatian I86A to th~ outer sub ~1'I1~' of the outer core wall ~.' ~ . ~ . . .: .
ZiIA are~~one or more charnels ~OgA. The top ~ 309A ,'~r'be h ' ~':~~~or slope ~ ~ ~ ' .' : ~ . ~ : ~. .
~ upd~ or downward from indentation ig6A.. If top sur~c~ 3b9A stope~c ypward pr ~ ~, ~ ~, . . , ~ .
.'f .';:' ~.~'' ~ . . . ~ ~ . . ~ .
.:, .: ;~. . . ~ . dowiivv~rd~'8ron4'indentatton xA tai core ~d Zp6A, one s~illeet'ua th~;axt~wvoi~td~be able to ; . ~ . . , .
~,v > ~ v'~ . ~ e~ja~tthe shapes oi'upl~plate?.99!A and u~pp~ oars end.2.9sA~a~ecoi~diy. Cha~els~3o5A . . . .
' ' ~.:1 ~.' ~ m~yhave sn even depththrough ot~t the,length ofthe chsrniel A;
~3o~ayer, cel~ ~ . . -~~, :y;~.s.:' '~~ . ., ., ;, ~. ; . . ', f 1 . . . .
A may ~slop~ dovmwa~rd or upward rs~iially ~o~an the c~nt~to Ozer slaltad u~
fiho.art worrid.. , . ~
~ 1' . '. i' ~ - .. . ~. .see thaE ~if top site. 3tMA scopes ppward or downward mid has a c~onsut ' ,, ~. . .
. ..,; ': , : .; . :' . , . .ct~~; tla~' channel ~~SA'siopes inward or do°~ward accortlily. . , .
. . .
. ~ rii0f01 ' v Refer, iing~to Fi38, ?Ire botfiam surface ~9'A of upper~plate lC9!IA is ii~-~ . ~ :.
. , 1 . : . . . . . ..
-~ '~ ~. .'~ ~ ~ ~ : , di.~ect .coat, with t~e.top snuface ~a 3t19A of botoom~'rrore ~.lA vvh~ completely ' , .
: assl~. This contact forma's fluid tight. seal between ttte tWO surface ~~as forming an . . . ~.
:.~,,,,',,_:~;;s.",I'.~,°u ',, -;.., ~ ' :, ' v . '3~ . ~ . : ~ ~ .
. . : . . , . '.. ' , . ', . :~. ~ ~ .
~~ ~ . ~ ~ ~ . :' ~ ' , . . . ~ ~~~.f . ~ . ' . . . . . . ' , ~ ~ ~ ~ ~ '.~ ~s . . ' ~' '~ ' . ':
'.r .. . ~ . .~ . ,. '. ~ ~~ ':., n ~ . . . , , ; ~ , n ~ ~ . ' ~ ~ ' ~ . . ..
, .n . .~. ~''~ .~,.~ y ., .
'~' _ , S '~ ' ~ ~'. ., . ~ ~ ; ~ :~: , . .. : .. ', . ,. ~ "'. ~_' v, ~ .. P~ ~~ . n . . , ,. ', 'n~
, .. . . . w . . ,. , ' . . , '. ~ ' . ~~ . ~'. ~ ~ . ~' :~ : , , .: O~o.3E~.~o~13 #~'~ori l~iA to cbarmel 305A,. A s~oo~d t~po:~C ~roui ' ~ ' ~
; . ..
.. <, ' ,~..~ formed in the outer surfs ~13~ of outer oars will ~~~~v A.
°~he op~iag~ ' . . . . .
~ ' .< ;. ~05~provideg fitud~ ~ommu~aaatio~s~f~om iucientativn 1.86A:~
c~3ti~.~ . ' ~ ~~ : , . . .-..
~peni~g.30~.C to sepiort vo~rs~e x20a~ (FIGS, 3$ and ~4~.
°1'~ns'lluid.SBQ flows fluough, ' -' quit ~191~A azut s~absequently'p~sse~ through flrWbowl ~el 4~OA. hko~ flFaf ' ' a:; ' . ' ; . . , . . . ; . : . ~ :~. ' ' ' ~: ' ~ ~. : . .1?owhd_u.4~I1A, flt~d Sty4 then, goes to throu,~ channel SSA
to the s~paioi~~volume,' . ~
.' ' ;''..,:::' : .,,~yll~. .v . .' , ~ ~ ~ . ' ,~ : ' -. : . . :' _. ; . . :
. '. . , , , . ':,;.,'...:,..
' ~ ~ppl~~j ~~ ~ , ~ . . ~,eferti~ to Figures 4~.A, 4.4; the lower cord eW A
t~ a lower plain ~ . . . .
a . . . ' .: has a t stuface 3008 a bottom su~f~e 3000 and o ~ '~ ~ ' :: ~.. ...; .v ''. :3p0.A~ ~ . W ~ ; ~ . .' $lD. ~ , . a , ..
i .~. :: . ~ .#rox~ lie m s3tltiC of the lower plate 300 are ode or ~
protiarws 301x1. 'Tbe .
': out~.edge 300D is adapt$Cl to be ~d 'to the lower edge ~I,ID of t~ie.otri~r.vore~wsll . ~ ' ~ . . : :. ' 1 ' ' ~~lA ~~nd provide' a fluid tit seal the~witb. Positioned above ~flo~jr'X84A,~ Iower. ' . ~ ' .. . . . .~ ~
, . ° ~' ' ,:; pINOVA, .is arcular ~cd. ~aEn'ves upv~ard radially from,~its cet~r (illusira~id yin L~C~ 44~:~ v . .
,. ... ',.:; . . . ... .. . , ~~'Alwely, losnec plate 3d0A'caa bye flat. As shown is~FIi~: 3g'~vv~as~ionc~i' above. ' . ; ' . ,' .
. . . . . ,: .,.. : , ~
' , -hoi~°flaor l~A; a~volume ZZO~C e~ci~ts beh~e~ lower platy 34pA'~nd hod floor ~ . , . ~. . - .
:. ~:.lStfA.~ 'funs ~olmne. 2~OC is in fhdd aomm~calion vvrtli sepa~ian volrm~
Z3tiA: 'dower ~ ~ . . ~. .
. a ' ., play 30WA;,. ~.y be msde~r'af pla~c o~ any s~thfx $ultablgr matensl.
'Ac3ditlon~llyy extending. ' , ' .. . .
,..,8ubst~tially~.perpcularly $om tl~ lower 3040 of lower piste 3dtl~l. is a.ct ~ ~ ~.
~~ ' .~$OA:' ~ Conduit 320A has ,a i~rst end 3Z0~ that extends into~ the apace betws~ lower , ' ,.. .
~. ; : pla~a..~i00A and lug ,floor l8aA and a sand end .3x~C that e~te~ils:
ab~ive tbn.top ~ . . ~ . , '. : ' . . : .,:~ ~ , ' 30QBof lov~iaac piste 340A; 'T~s dr ~f condwit.320,A is'ad~ted to:hav~~ a tig~ fit wlt'b, : ,' ' .
~~~ v ... :~,duit wall ~d 31~~. 'The volume; sn~.de conduit welts 3~4A
~d:,325A'con~tises.a~I:
' 'v~4tltll~~.''l~ volwnevdeflne~.hy tower plate ~A, inset sx~iC, ~d~
~aling:3~A Of . . . '~ ..
~ . . : :. : .. , , . ,~ . . .
-. bDttoin yore' ~QI~, ~ ~xclusecond bowl ,~anael ~ILOA, may cbai~i~is~ o~ air or a solid. : ; .. ' .;..'.~~~~~y ~ ~~. ~ . . . , _ . . :i ~ .:' ' :. . ~ . .'~ .' . ; ' :;
' . . ~041ti3) . ~, ~ Ia atz alwe embu~im~rt of the present ixiv~ion',as ~:
#n'PTtI:: 53,. :
1 Wit. s ' y: ' i;~.y~~=<''~.' .: ~~ , support wvetls 40~5A a~d~ AO?A may he optional y P '~I~ 40~A adds: ~
.. .' ~ :~ ; . . cuiarly fretn :bottom su:~C~ 309. Suppart wail ~iOyA.ex~rds"perpe~.a~stly from ~ , ';:~>..:: ~ ~' suae ~tIOB of lows late 300A and' cv~n~ts with s ~ . ~-'w~ti-!A
wharr'the ~ .
y.~:'~'.,.~. . - ~ t~'~.. ., ., . . . . . . . ly. . ~ . . , . ~ ' ~ ~ . . . .
;.yore 201A~ ~: assembled. Condu~ wa0 ~324A'may~.be, cec~d ta-,'conduit 3~A'to ' . .
c ., , . . . i , :.:,'.. ~ foiwa. . .fluiid tig~'sa~ and conduits ~~4,A, 3~oA may be cea r~pectivet~ vvit~ snppoW ; ~ "
i<. .. ~. 1 _ ,~ 4tIaA and 4tM~,. Additionally present ex~ndmg from. 6o~sm ~tce~3ao~ of ~ ~.. ~ ~ .
v ', , v ~ : ': , . . ~ ' ° , ~ . . . , . ~ .: . :r. ~'~ .. . :" ~, :
~. .' , . ~::y::'~ . . :, ::
~,.~;Y~;':,';..'~'.,~~ '.." .,' '. ". . . .~ ' ~ ; ~ ' ... W i . '. . . ,...
.. ..
:. w.,, ~.:~."'-.'~;~,~~';, ': ;.'.' .a ' .. , : ~ :. ' 33 .; . ~ y .. . ~ ~' ; . .'.- :.
,. .' ~ ' ~ , ' , ' , ' ~ : ~ : . ." d' . . ~ . ~ . . ~ ,. .:. .' . ' :.
.":..;. ;. ,:: ., . : . , . . . . ~ .. . . . ' . .'... ;. ~'.,''~ .' :,'<;
..,.,. .. ,, . ,,: ~ , . ' . : . . ... ~, ;~ . ,..' ~ ". . ~ . .,.., , , ;;:., :,." ~~ _.~,; ... ,..,.~.;~ ;-.:
;,'. ., . . ....... :, ,, ; ~ :,., ~. .. . . - ~ ', . . . ' . ~..; , .~ ~ . ' ~:; , ..,v' . , ~ ,;y, . . ; .
', . . ' . - , ;'~ . . ~~ ,. ,' .,. ~ .~ '.
~ . ' ' ~ . . .
.':';:~'.~ .-'v ~~e '.. , . : ~ . ~'!. . . ' . - . , " : ,.-1.....:,..: ~.:::
' ' . t. , . . : :. ~.~F . , Lower Plato 3UO,A ate one or more or~~stion apa~nrs 409A that ante 'ind~ . ~ ~
' ~ ~
:y-...,:,~;~ v .. ,~.;. ~' ~.1.~.'~:<~A, '~ ~ ' . ~ ~ ~ ~ ~ ~ . ~ .. .;,~ . , ,~ ' , . ..' ' . ~0ol~dj y, . As will~be readily apParmt to'onee of ~rdin~ alcill~ in tbo art; the bowl: i0A : ~ , ~ - ~ y ~.
v: .,' -'' :::willyd ~tao' be ba~~at~ about it ~cie ~ lA. Acco~dur~y, v~'e~;y'i~e added as part _ .. ' ,;,-. . . . . . : . . ~ . : , . ' . . : , ~ ;~
- . ;:y . r. ' .~ . - of tie ~d~vice as is sppropriare to fac~litnte ~~anci~,g of t~ bo~wt ldAi ~i~. a~ .woi~nt ~ -~ ; ... ~,; .- , . :1 ' , ~ . . . - ; . ~ . ~ .: ''. . ~' . ' . . - N' ~
. .; . . , i ~ . ' '.
-~:,'Z : . -;~~SA tided u~ FIG' S~. , . ~ ' . . . . .
, (Otll~] ~ , Ref'~ta FY4~ 38, bowl 10:~ is adapted so ~tt~t.~ciu~ihowis~ng &OOAz cprea ,' _ ~y . ' . ' ' ,; ' ~:~vpA aru~ 2oi~A, lower glate 300A and upper plate x99A, hou ,;sin, #l4or iSQ~A, ei ' , . , ,~ - - ~ ~ a~nduits 20A ~d cormeaior~ sleeve ~5iD0A,, arud lumens 400A and ~OfD~ ire ~n'oaronon ~ctd~~~ ' :~ ~>~ ..:e.~g~er. N4using floot ~,80A ofou~ housitxg lOtlA co~rise~ ~ ~' as ~glA~on its' '. : ~. .W : ~ ' . -.
:~:~.;:~.,. , . . ; : : , .
. said thsse rreccesses are to 8t t<usion 3~1A o~lo ~~e ~ll~A. : r~s . :. ~ .:
. . .
~~ :' ~p~ .:. .. ww' . ' ~ ~ . .~. ._.. . P.,~, . .
, -~ i'~ ; .; ~ . ' r.'show~,.lov~,plate 3~4A less ~muad protrusion 301A on,its~bottom ~ssC to riot -' 'i.: :' ' ~ . .
' ~ : ~movof lower pl~ 30tldl with .respect to housing tloo~r i8a~.
VVt~ac.'s~nbled, each ~ , ~ , , ; .,.y. :: . ., . . . . .. . . , : : .. , f . . : . , v.~r:::.,: , :, y:pr~siron',i0~'A on ~e bothoa~ sutfac8 o~lower plat~-30p~1:~oi'a~ ~ ~igl~ ~'t'wYth ' . . ,' . .. . ..
. ...;-:.::w~: , : ~ . ~ . ~ : ~.. . . . .
~~ ~. ; ~ .;: rec~$lA on housii~g~ floor 180A. : Thus, when outer housing:
~sOA is -ro .d, , ~ . . : . . , . x00 , ~ labe~~299', v bottomi core ~. ' , "'°~';:.. .; ' :'~ -., .. ~ i~it ~A snd.~can0ec~io~n ~leevc,~:ctOA,,'top core A, upp~.,p , A, , .
.: ' . _ ~ - ~ ' ~ r' ~ , , . v ~: ~0 ,lower plate 3~OA,' hat~si~pg floor 180A, and luiue~ 400A
~d.~Bvovili rotetey ' ','..~,: '. ;',r,: ;~' : ,'.. :_~:: ., ~, ,. , . ; , . , .. . ; . ~ . . ,~ ~
, , , ' ' ~ ' ~ . . ' ,..,' ~:.~,',~. .,,~ ~ ':~ , ,°'~t~, ~ , w . ~ . v ~ .~ ' . . : v ~, .
. ' .
,~ ~~fl0~~61 . ~ As illuetreted in FICA. 3s ium~ ~0~A allows w~l~ blood gibtt to oome icrto'.
,:, : . . , . . . ~ . .. . : , , , : , . .~: ; . .
;. : ;, ~,' bo~llnA via a fist bowl ch~u~el 4$oA. First .lidwl. ch~mel ~2gA:
p~ovid: a p~ge~~way 1'ox v:: 1' . ~ ~ .~ f'~ ui ~,~80U ttiroc: ,lumen SODA to.~on.1S6A ark t.;o tha'o~
volt~ne : . I ..~
. iritl~a~.v. o .fl d gh :, . ''':;<: ~ .; ~..: . ;;.~.:: ..y ?.x~~'dfr channel 305A. Lung ~A is locateed' i~uside tcp core ~0t~1. ~ Ltttn~ d00.A, ~ .~ ,' . - : . . ' -, .. ..
w :. . . . . , .. . . .;: . ~ . . .. ', '~ ~ > ' has a:~ifcaux e~pp~ lumen er~d ~A end lower lump end AQ~~, 400A~is .
~
' .,~.... . = :. . . - . ~ . ~: ~ ~ ,.;
,; ~ pby the aonno~n al' cha~ael welt ~01A ding ~&~ the'iru»~u~ace ~SiG of .
"~' ~ . , , ' :r .:; -. ': ;,. . : . . . . - .. . , . . . . ' '. ..r' °. . . :~~;. ': ~ . '~ . . -- , .
~,-- ' , v ~~ ,. ~. ltun~tt C~t~ctor~4&~A 1 wall 4tt2A ~t~din~g ~roni ~ei~top ~ A.o~'~pet .y a iur ' 1~ of f3~ Z~IA'wv'hicls ere att~ch~d:. ~ - ' ~. .
. . ; . <..v~ , . p~~te ~r~. cha~noi wa~i ~oxA ~ ~up~or~ed by p ' . . . -~ .... . , .
' ,, ~' '' '':.. ~~ - , to the user wall.sux~e x>IIJC ogthe outer core wall ?BOA ~c~' ~ec° sur~CB o " . . . . ' . .L"; ,. . ,;. .i ~ . . - . .. , . . ~ . :: ~ ' ~ ~ . , , . . . , , gel: care~,ertri ~Z4SA~,. and ch~nel wall-~3A. is s~apport~'1 by a plur~t~
o~iit~s~ ai~iA (FhGr, ~ .
.'~ :y'.. 4a):~it c~ r~di~ly b~ set tbaa height o~ 1» 400A c'auu be a~uste~ by c~a~'mg"th~W aas ~ - : ' . ; . : dies o~f core A, gannet wall 401A, chl wall 4U~A, cc~dt3rt~~val132SA~, and. t~ ~ . . . .. , ~ , '''C ::G ' ~' "; . . . ~ '..F
.' : d ~;.;.;~~:"~>i.,~_,.~..v:.~:.~ . '...a ag. ~ ~ 3?~A. ~ ' -.,. ~ '. ' . , ~he~.. . y wad ; . ' ' . . , . . . .. .
'' ~ ~i' : . . , . . . .
': . ' , . ~901t17j ~ As..ilY~ ~ FiCi. 38;1um~ 400A, froaz ulsper In~en ~ ~e~d 4~30A #~o lowea~ ~.
.: 7..;.i ~~,'q '.. . . . , : ~ ' . ... "
~ . : .' 'i - ' ' . ~ . . , ~ ' . . ~
.. >' ; ,,; . . ~.,~~;~ ~~O~s eu. . .innetr;lumeu 4008. 1'.ower huuen'.m~
402C~' bass an O~ang ~ . . ° , :~ l 1...'~A~,.,~'J :~ :~...~,> ,: ~~, W , ~~ . ~, ~ ~ : '..'~ ~ ' , '~~.; , ,'.~
' .~ ' _ . '. ~~

~ ' .' . . : . ,' . . ' ' , ~- , ~ . . . . .
' ~ ' .' . . ~ ...l., . '~~ , . ~~ _ ~ r'''~~.'.~,,-~:"-, . .., , . . ' ' . . . ~ . ' ' ~ . . ~. .' .. .' , a.

, : ,~ .~ ~ ' . , ' '.Y ' ~ . , ' , J .
J . . ' ~ . . .~ 1 , :' . .
. ~ ~ ~~v~W is in $uid coinmaudcatian with separation voluche ~2t~A; a munber of .. ~ ~ , ~ _ . ; ~.Tn the zllusirated et~odirn~nt lumen 9~OtfA co ' e~'t,~owl'cb~nei. .
., ~ ' ' .
WZt~A: SecoOd bowl ~I ~tiOA.is located inside fast bovuy'cI dof the tflp: ao~
. ~ . ~ .
.: ..y .., . . :.;. .:;~ . . : . . . . . . , ; . . .. ' "' ~ an~v enclo&ed thin horn huneu ~d ~BQA arid to Iun~i~ .C. F~or.~' . .K ..y; ~ : . i . .
~'' bow3 .channel; 410A fOITTIB a pt~~y throiIumela B; fmni; ~ ~ ~p ' . : . _ .
'° ' . . . ; ~belovt~ Iov~ . date ~.;.'~~~;:'=~ ; '~ < ' ~ '~v: foi the re~ov~ of ,~ $rst sepa,~ted fluid component 8.10 t~,t~.g.ind~it~o~ ~ ~ ~' . .
., ..v,:-v '~h w y'. of~o~g floor l~$DAi,. $~id bowl d~asmel 410A s from holing flo0~r ~80A. ~ ' y , ~ ;.
..,~'. n'~ - . ' ~ . ' .. . . ' . ~ ' .. T . . . . ~ . . ' . , ~ ~' . of Ot~ hon8ui$ ~OOA ~~d~ou~ 4~OB and to conduit c~an~l. v~60..~!'. , nil' rondwt~ , ~ ~ ' ; .
~':'''~ .:,,~;.,,: '.! ~:'':.~ ' ' ~. ~ ~ ~ . ;.~.': .'~, ',..~,~ '. . ' :, y:. .,. _,:::
.. . . :
~~ ' ~ . i : ;
:.[pplpg~ Ref~r~ing Figure 38 (~hha~wn without eonduit 3~ICj, ilun d0o8 ~Ilows.. . _ v .:_:: . . .
~'~' ~ v' = :~ red~b~ood r.~lls S~0 ~o exit ~owI IOAvi.~ a, a second bob ~l 418,A~ t~roYtdes ~fluirl , ~ ' .
:,w.:::: ' ~ .:; ~ , . ~ .. .. ; x,#E: ' . , ... ;
Woiunson fro~t:#he hou$ing door' above xt~d~ ~8BA;'bo ope~g~ ~ . ~ . , , ~ , ;; ; '~:; ; , . ..
:.. '° ~r lu~ien,:4~Ii8 tip ~i upper conduit arid 3?,~C and .a lower conduit end °~?~t8~ pit ~cornprisest~ ~ . . . ~ .
.~ : i' 7 ~ . ' ~ ' , . . . , ' y tvvp'couit vvelL9 324A. aid 325A vu~iCh s~o connected un. a t~uid t~t:~ foam . ' : . ' .:
. '~''~.i.'.~.'~~~. ;: . ; ..: . , . : . , ..
-s." . ~ ~ ., , . . . , . . . ; , . . ;.,i~,..
. ~ ~~~ secorid,'~ow1 c~ni~el 4loA ~t has ~ smalleer diarn~r then and is~ss~parats~:aad dis~iu~ct &~n1: .
~~~ffrst iiawi a6annel ~atl~. ~;omduit n?nll 3~8A,.is~supported by a ~.,A, that ds~thiough , ~ ~ , . ~ ~ .
,:':~ ~,';.: ; ~ .': . : . ~: ~ . ' ._ .~~,' .
., . . .~ ~ . wall 40IA sttd~ attaches to cflnduit wali~3~5A. U'ixTilke lung 4.00 which h~s.one , ~:~..~: ~ ~ ':.' ~;~ ,,.r. ~. , .':Wd iaue~' i~I~bA~ lumen r480B~ ~ctends beyond' ~~~86A~~ati thtou$h : . : ' ,' ~ ,~ ,~ , .
,'. "''late 30~A» 'ihhe Stet conduct wall 325A lies an nppe~ end 3'which' has att~ . _ ' ' . . - , ..
v'~4~:~~:;v:~.~:::y.w:.' ':P. .. . . .~. . , w . ~p 4S~A of Iornen co~naector 481A aru~ a IovYei: end .3~5B
. ~:r;,. .yf ' .oP:~~banthe, a~irf~ ; . : , : ~ ~ . ~ " . .
. .. .. : . . . . "
. ~ ::.'.~ en opening 3~8E adapted to .ft tigh~y with' upper ~ 3?,~C ~
eoric~~tit, wall.3Z4A, ' ' , ; , ~ .
,.
.. ~ ~.~,:..: . _ ~ ~ ';U~~r~~ 3?~C of o~uit wall 3~A is higher' t~
i~lon.~Bl~A~a~ rise. an 0° . , = .
' ~ Conduit wall'3a4,!! also has :ertd' lower ~d 3~4B seal is a~~ed''~Ya~p'Y
°f . '.
~;-, , °: ~ 3?~D, ; , ~ ~ ~ ~"~ . t 320A v ' ' ' ~: ' . f~ . Lower end 348 having o~P~ing~3~SJE ~ adapt~d xo ~'~ . . ' , . .
. . - . ~ ~,~,ing~opeaing 30~~aocaied x~ar the car of lower plgte ~)0&. ~ The o, 'oi~oc~.on~af , ~ ~ ~ ~ ~ . .
. ~ ' ~ ~ 3 E aad'3si2A. rovid~ flirict ror~imnmication b~ Iuz~ B' ;W ~~ . . ~
, v : ~~S . . g ' ::~ . ~ . . , . . .
~ ~ lower. ~ late 300A said Itonsin~ floor lBtiA. 'tee, spaoo ~~0~ bet:cveea ~awc~r : ~ , ~, v ; ~. : ~; ~ ',, , v . :~..:
.. p. , . . ' .. , ..
y, , : . :p~~,~ ~ '~u~lg flornr 180A ~a turn lies fluid comm~micariore :with .~. ~ ' '~ . : ; ~~ ' , , . : ; ' :. . ~ 1: .. :~ :,: : ~ ', . . . , ~.;~ '' :;y ::
....' . . . . . , ,. ' .,.
' ~ ~ $~A ~~d~ ~ ~t ~.Vlt~! IOW~I,' e~ 3~~, ~~ ldlllg ~~IppOlt fOr ' ' , ,:;:. ':. ~ . ~~~~,. : . _ . ' . , : ,. . .. , . : ." . , ..
': "~ ~ T ' ..~88CCspd bowl ~Ch~tel ~41~OA, . Lackt bowl chWrrel ~~OA srtd ~IfOA. may he a o~~$' 'ty~ ~~~~ . . ', : '. ;
.. ,y .~ ~ 5 ' ~ ~ ~ .~ such as medical tubs oi' ether such ilev~ice pmv~.dis~g'a sealed ~
~ . . . . .
~.,~ .fleaci~ , ~'i8i ~~ : : ,.'.~ 1 . . ' '.,', .~. ..,'~.~:
°'; ~. .t vy. ~ v: ~, ~ ble or . d tubuig ( . ' .. ' ~ ' , .:. : . .
° ' . , y~ ~.v. v . :
' ~~:.;~~' '~., . ~ . . .. . . .~ ~ ...
'~~: ~~ :~,'.,'iS ~L~k?. ~ ~,",. ~~:~~ ~ ~' . ~ . ; . . ' .. . , ' . . _ , . -' :'~' . . , . . ' , . . o . . . .. . .'vs .. ~.S' .. ~~ , , ,. .., v?.: .,r ~~ . . ~. ~; ~ ~ . . ~ ~ . . . ' :~ . ~ : . ; .: : ~ .. '; ..
. . ' , . ' , ~~~~~~.~~,y'.... .: , r . ' : . . : ;' ~. . ,.; . : . . ~ . ' , ...~ . .1.~ : . .' ~" ~~'~ ~ :1.. .. . ~ . , ' ' . . ~ . ~ ~ ~~~~ ~ :~:~ ~ , v :... ~ . .~ .~ . ~. .

' . ' '~ ' ; , ,~ y ; . ; . ,. . ,.;,.,, , . y :.. ,; ;.,:, ...
.. , . :. ~ ' ' r ~. ~ ~ ',--'.:
. ~ ': °. ., .: ;.: .'. : , ~~~~Y~ po~ibly ~ar pre~suriz~'or.rmpress~ai~ect fluid flow,~ai~tl lw~ri~c~i~re~e~rably c~ ~ .. ~ ~ , , : : .
~:i;: . .. '. .' ' . . , : ~ . . '. ' . ; , , .. 'tie.~tspas,~ble ae~d steri3iz~b~Ie, i.e.; of si~npie and e~icie»t manuf~ct~.. ~ , . ~ . ' ' j .
:' ' ~: , . , ' ' ~ :.. ;! , _ ,. . . ,, . ,,; ,: . y,~.,: .' :..,:.
~.~ ~~~~ . .
.. ~ '. a; ; .;.[tit~l,;~,0] ~, As iliu~br~cd in p'IC3~. ~39A sand 39$, ca~tduit a~se~tbly-S6A~Ais eed.to ~ ~ . . . . .
.~.
....bowl 1aA ,via co~ctio~n asleev~e SOOA, which is fed ovto the .f#tat errd S~xA' cd' eacte ! _~ ~oonduit.ZQ~ hawing ~ first~co~it channel ?il~.A, a second conduit "~68A,vand~s t~rd , ~ , ~ ~ ':w . .
,, conduit cu~el T?BA,. ..Lack ocatdctzt :l has ,fluid camu~uni~tiori~ wi#~-a fltst: b~o~irl .
.,.. ... , ... . . : , ' . ~; :~.47~A, a seoo~ad bowl ~ 4i0A, aud,abowTchamber ~4~i~1. v 'ih~
coadc~it ~.
' ; ,ciS, are e~aiiy spaced 120° esnd ~quel i~z~ deter in eXt~COriduit ZOA (See , , . : ., ;
~t~: 30),. ~Nhet~ fit~idl~r connect to cozuluit 20A arid bowl: BOA, coi~wit chattel ~ . . ..
~.~'7~A:~~ Sitidiy coxmected with ~#rst bowl cal 42bi4~, for iotlowitig tliaid';fi~,ma'at.
con~l~t~ 2pA into bawl .loA for separation' Similarly, seoo~d ~ yt ~spA
Seiidl~~. . . . . ., ' .
w3.. . ,.~. :'. . : ,. . : . .. .; . w :c~~ to.eecotid b~avvlWl ~1~A for removing first sop,fl~d 'dent 810 , ~ : ..
', . .
:y: :. ~ ; ,; g.~~'~vv1v1.4A into ertsa~ conduet'.~A.' Finally, third coondui~
l'?~'OA oo~ect~.to ~ , ; : : . .
' . . . : txsr~i "1M1,A for removing ascend s~ar~tcd $uid co~ar~t 8211 rn'bovul 'l~A. ~ : , .
.. y° .]00;~~)' . . ' ~ As is'iflustrated in FIC. 45, conduit ~A. has a o . . 'oan~On~ sleeve en the first end~g6~A, a»d an si~Or sleeve 830A, on.the socondveaø°S62A
of ~sternsl . ° ~.~oo~d~it T,OA. Qptionally pbetweea~'1~ cantaection slieeve SODA
eddy ~uchoi alee~ev . ' ;. .. . .
. ~~. y,~'; : ~ .,,~:~: .: .~ ;' ' :, 890A, oi~. catt aOA ~re~ a first shr3uld~ SSa mtd ,a second s~ould~r~ S84 whicl~~
' . ~ ' ' .. . '.
. . . ~~ e~ctt pe~ndicutvsly fromthe external co»duit ZOA aa~d~ arc of a l~g~rr ~di~ar : , ' ' .~ : : . . ..~ . . , .
. . .'i, .~ . ' . ~, the~..cbn sleeve SOOA dad au~or sleeve 8°~0~..(or iFpt'h~e t~.~r~d second . _ ' y ' ; , ' . ~ : .. v ~shou~'der'882, 8S4) are a first anal aeoarnd y.rin~ 871:A, '~$"f2A. ~cte~al' c~d~it . ~ . . .. . .
.. ~ ' ~~ r .. .,. ~:..' .'.... : ~ , '' ZO~,~'r eleeye:8°~'OA, and ooan~tion sleeve naay be prepared, firism thb'aanu,'~ar ditferea~ , ' ~ . ~ ~ocompa~bl8 mat~cials ~af suitable ~ arut ~le~ii~ility for t~e'iu~
this :fyype oftubiag izi a ' . ? . ceif(one sorb,prefe~red is FtYTREI.r~). The co~m~cttiioa s ~l~owe SUOA
adid,the _: , ~~,,e $f0~li mad! bo attar thraugbi arty auit~ble means stab: ~;~
1'adives,: woI ~din~g ~ ' .
. :,. ' ~., ~howewer, fox Vie' of ~'ture it is pre~rad f!the o» sf eeve 5otl~~b,~ and ~ ~ ~ .
. ... . : . . . . .:;. . . . . .
' ., ,:,. : y: .' . :.: .. a for sl~v~ S'10A..bti overn~oicied~to fho rns1 conduit ZOAw ~ ~ ~ ~ , ' . ' , . _ y.
. ~00I1;Z] ~ : ~ ~ to F1C~6. ~5, 4~ and a9 anchor sleE.we 8'lilt~ yes ~a body 8'1~:,; , ~ ~ .
v . ' ~ . . . . ~ ~ Y .
.h,~vi~g a' fast anchor end 873A a»d' send anr~r end 8~4A. ~At~hor ~le~ve 8~i~ly . ~ . . . a . , ~. e~otal cxnduit Sri s6x~1 of eternal conduit g0A $piablyby ovenuoldiny . .'';~ .; ~ .;.. . ., . , . . . ' :i. ~ ..
andines in diatnfrond ~t collar 873A to the colts; 8'14A. : Spa "cad dist~ly f~o~- , .
' w 86 . . : . : . ' ' . . ,' . . ,; ,, .. , .,, , . .~ ~ .; , ~..
., . '~: ,: ;. ;.:. ..' . . . : :, ~ . : ~ ~ ~ ~ , ~ , . ~ , . '.. ~; ,. .. ,:
.:' ' . . ' : ' . . ... .' ~ :~.. . : ~ ~ . ' ., y . . .. .. .~ : .. . ~ ',r:

,' ; ' . :' ~ ; . ~,1 ~ . , , . ;~, . y .. ;'':; ~:
~ ~ ~ , ' . ~" . .~~ 1.~,:.,,~,.~,.,.,~..~.~~.
. 4....j;i':~~' ~;~~~~1~~.;,;'2.,,..vi,,~y, ... 2 . ~ i .. , .. . . , ' , , ,' ' .N~~'~ ~ '.~
_%' ~ana.ena g'~4A is a collar s~dA, wliicb extends ~y ~z~ b~~.~T?8 y a~a ~ . ~ ~
'. .
. . .: ~~~ ~ ~,~he body s'?"1s of the anchor sleeve ~7oA. A ply ~
ifrii~.s7?'A, ~ ~ . . ' ' ,' ' ~ :: .:~ ~:. . " ,., '~.a fnrst n'b~ end 8'7'~B between the coihr S~A and second aoi~ ead'~?3~, antly ~ ' ' ~ ~ .
.'J~:I~-; . . ,~ w' ~. . . . ~: ,j . , , ,S~C~ ilb. ~11(~ $'~~~ l~t$ be,~017~ '~C ~rgt SttChOr 8'~~1~ ~~t~i~ tb t118 bOd~' ~ ~ ,. .. .-~. ~' . . ~T~. The's~cond n'b ~s S'~TC are'oinsd #o . ~ ' v84A; lvvbich~~s also. attac~d 'v' . . . . v , , . ...
. : .. ~ . . ,~ sue' ~ . ~ . ~ . . .
' v .: 'to ~ .conduit ~oA, The ribs 8'T~A rus gar~~ ~ tl~e ~ conduit h~ and ire' . ~ ' . .
. : ' ~': , . ~~ .v ~.;g~alily placed oval ~tha region where conduit chsuaels 'lbOA, '9?a~, ~Sili~, are',close5t v ~ . : .
to the aurface of the ~ conduit 20A. (~'IG. SO~. ~ ~ regions .vvb~
tb~.canduu~t c~im~els: ~ ~ ~ ~ ~ ' .
. ':: _ : . , : . . . . . . ~ . ~ . . ~ , .
.,.~-., . ' ~'6~A, v'xAA auud 784Ar'~; a~ iclosest to outside'd3a~e~r of ~
~nuii~i~t BOA ~ml. . .
' .. .. ~ ~. ';~ . ~,'. , ~~ . . . ,.. A . , ~ ~ ~
.:rOi~cea't~tl.to:faxl,:auri~g high.apeed ~aotation. Haviaag fibs ~le~
withithe c~oiWit ~ .
. .beyond flat anchor sleeve ~sd 873A provides r~inforce~t, to .this, sari and ~ ~ ' . .. ' , ~ . . . ~ . .
'., ..:::pr~~s: o~iuit'failiu~ at' I~tgh sped rota~a Zn ons aspect, the ribs ~risv~t the' budding o~ . . , _ ~ . .
s .,~ ~ ~
. . ; , ,:.''' ,~ ... ~~~nduit.~A ~ this re~i0z~,aad act as st~Gtu~
el~rri~.~t0 #rfea~ #~ to~Onat : ~ : . . ' 8's'rd.~. ~ : ~ ~ ~ ~ ~ ~ a ~ . ' ; ~ ~ .
~.. . , t0 tli~~ : , ~ , . . . . . . . , ~
. ..3:: r.
~- , , :jfl11113~ . ; . ~onii~Lo~n. sleeve A co~napas~ body 8~A h~tvin~'sn ger ~sl~eve esed ~ , '. . .
!: : ; ' . . ~831A; end lower sleeve end 1~3~A (FIGS. 46 snit ~4?'). . lower Sleery~ &'1~A b~ sleeve ' : . ~ ' '~~QA 8 ~I~' 1~1'Ot!'l~Sl . , IX1~~1~tt0II~ v ~' ' ;.~ : 1~~~ a~ ons~'843A, which Sty sito e~,$f' ; ' ' . . ~
~84,~! ozi thewall ~urf~e 48~2J4o~tartmectox 4~1.~A,. Why t~'~boovt~lit&
is:asled, ' . .' :.
' . . ~ ' ~, ~ ~ . . - v " ' .. : :a $ind ~tf ght., soul 'n~a~r. be piovided by glaG~ng o°rmg ~'~9xA m~ou~d' bo~yv3t~A~ a~td . ~ ~ ~ ~ . ~ : .
'.. ,' '.:.~ , : ,~.~ ~°~P~;tbe o'fu~'f9l~Pl be~we~ fl~nge'r9t);,1;
aa~d~hausi~ Z~OX. l,fir~ed~ve end ~ ..
~. ,831A is ad~gterl to be. s~~d t0 l candwi# ZbA, ~teferrin,~ to ~Q. '!~6, 3~A and 398, ~ ~ ' : ' .
. . caririectlon~aleeve :~tOA is s8cored tb bowl l0A b~ mea~~of sleeve fle~~90A.~d' ~.
' i. ~ i ' , . ~ ~ ;. ~ ~ ~: ,. . : : ~ . ~ . ' '~ ', ad~pt~d:iso $uidly coimect conduit cba~Is ?I~OA, ~'60A', 9f0A~pf ~
~iduit 20A to ' ~ ~' ' : .
' _ .; . ..
bowl chapels 4~OA. atul ~ 18A, mad :~ 940iA. ref bowl isA. assembled,: ~ ~ ' ' ~ _ ;
~; . ~ r coma: al~o8v~~':1~0~! is ~mou~'to lutnect co~ector 481A ~5. 39Ai arid' 39B): :
' ~
:~; ,' y::,,:; . .'..; ;.' :~, ~ ::, (ABI~~j, ~, ~ . Coun~ion sleeve St~~A
gre~ably yes in ~~ ,~ :. ,.. _ f~orr~ ~~er slew .~ , ' ~~; . ~ ar~i,$31A to lower sleeve eszd.S3~~ and is ovialded to'first~c,~i~dr~it 8GiA of ~: ~ . . . .
;v: E. a ~... . ' ' : .; ~ :.~~ve 5(~iiA .bo~lrUA to~~co~tduit 2tlA ~wi~lo~t .~
aii~t BOA. ~Conon , ~.JyS' ' ~'~~ r ~ , . ~ ; . .~ ~ ~ , , i . ~. v.' ; t~:op ~,, mtatable seal, which wovdd use normally be located~ lwe ~~ bawl 10.x! and :: . ~ .
. ; .. .: : . .. ~ . ~~
".~ ' .. .ion sleeve 300.A. s~d~~ess conneøtton bstweea howl ~ iaA ~'~
vomnect~on.sleeve ~ ' ' ',~ .., ~ ° . ~ SOpi~ ~ ~ ocetar as ~ ~ lai~ied above. or weI #bro ~ ~
use. o~ tbr ~ ~~ ler ~ari 0-titi~,. n ~~ ~ ~ .~3' . f ~!: ,.
.. ~.~::...:.;':~ ~~ ~ . ,~~.:~~liP~ ~-~YPe connecti~; weldir~; ar a tight 8,t wit~~or w,~,~hout adlie~weyn °. . ~ , ~ . .
~'~~:.':~.~'.~:~~ ': ',r~ .~' ~' ~ y ;; ~ .. .. : . _ . ..~ .~ , ~ '~: ~ ' ; v ' .. ~' : .:;.:.~. ~.. ~ ::;:
. , ~ ; , ate bowl i0A or. poet sleeve' ~1A. . . . .
~ . . . ', ' ;:,y ~.'~y:',.;~' -..;~,<:, , y . '' ~- ..~ ~t ~~...,:' :. ,~. <. . ... ' . ~
. .: ;..
:~'.;x":'~,.:. '~", , ~ . . ' ; ' ..:y' :.f°~ . ~~ v:~~ v ~ .~,~. ., _... ;:.; . .: :.~ .~~y; ., , .. ; . . . ' ~, ., ~ y,., y-~ ' ~ w ~~~ .., . .
: . .: .. ' ;._,,..; .;;.~~~.,:v. ::;.~:;n.:
: ', v~, : .. ; ~ .. , ' . . . : . : ~ .. . ~ . '. ~ ~q , . .. ' ,' ,~, ~ .. .
, : ; ~ .: ~ ~~ ~ .

:a<
~ p . .. : . ~ Ny ' ; ~ . ~ ~ ~ ' ~ ~ . . ~ F , ; ' ~ :' ~. . T' ~ : ~. .
~ ~ . . .. ~ ' . .. .' :
' ' : . . , . . ' ~ ",.
.. . ~. ,. ' ' ..
.. , ~ . ~~ . . . . ' . . ' , , ..1.
~OIiilS,~ ~~ ' ~ AS ~llu~a~d in.Figuro:~66 a~bd $9B, sl~Ve.tl~ge ~D~,''h88 a,~botto~i't sul~Ce . . : . . . , . ' y~A ~hat.co~t~s vc~th;'top surface ~B~;A of Iuraen aor~n~ctor 481A fa~a tic :~,1. ' ~ . ., , .
. : ~,~':. .' ..:;~Iowev~er,'cormector ~48iA ~ a plural~ty.of ~nde~tstxoa 483A
tta~' p~vides for fluid: . . . ~ .
corrniuiai~ation ~atvveeo ~eps~ration chamber aZOA, and bowl clxamber ~'MiA ~
which; m torn . .,:r., ~ . . ., ,. .. ~ ,s : . ,~ , . .
,hasyid communication with condcdt gel T9ttA, Howl cbanaber'?dO,A,; ~r deSn~d'b3'. . ~ . . , ' rs'~51.,~1 'ate ~ aur~Ce ~182A of lump coatflr d8 ~: ~ . eatcl ~ 111e : : .
. . ' unit . '~P
'v ' , ' ,' ~ ~ , o ~ ied #~oilo~cw finders 3~iA aad 32~A. ~ Iur~' of 1 ~~rs ~3Avon l3~ ' ~ ~ ' ~ .
, bY cY . p ~~3' 'p . .. . . , . . . , .
~,.. 'si~rFace 84'iA of sleeve flsu~'79~A ~,ga~es and slides into 3n~oris~484A
an the . ~ ~ .:
~~ Ofy COnOf 4g~,~s 1311DVId~$ 8'~1$~1# fly. , ' . .
~i~i~~. ~ : Connection shew~ ~O~A hips to secure ~ conduit ~O~i to bo!w1 iOA, ~ . ~ . . . :
. ~: .3 .
.~u~;fluidly eonue~ttg.n~a3 conduit 20A~% bowl i4A, This fluid ~onti~tian gables ~ , y. .
.#luic~ X00' ~o be ~:applied through e~ea~x~al conduit ~tlA to bawl i0~. ;
~a~Y. ~$ttid ' ~ ' ::; ..: . ~~. .:~ :.; ;.,.. . . ya also e~bl~ ep~d 'd ca nets 8~0 to ~bev ~ ~
~ ~n bowt~ ii)A . .,..y . : ..
;.. : cona~~t ~ , ~ a ed Plat m~po b, , ~ r'~ fro ~ . , '._ ~ ~. v~~,' _,..;.';v:;~y ~; ; ., ,ei~rnal ~t~~24~A. ' ; ' ~ ; ~ v ;~~ ~. .
: .
. '::, ; ~ .jO0lXa] .~ . ~ conduit BOA ~S apt appro~ately:co~ta~ di'striei~r ic6 helps to y , ~ ~ . . ; .
. ~~A ' ~ .;.~ rtbevrigidiity. : Atr oxcesaivelg rigid ~ conduit iDtfA vv~l hart'up' ~d. f~i1 ~rw .
. .. w ;~: .. . . . ~ . ;~ ' ,. :'~:yurdrly. , Additionstly, ,a conQtapt dialer conduit is cheapless~~tn ~ttu~.~e, maws ~sy ~
. ,, ' ~~ion ~witi~ ao~..tion sleeve SODA aa~d anchor sieve SyOA siz~a, and ~
~lti~ws ~, . .
. ~~ ..bearixjg. dings B~IA; 8'r~A to be easily slid thcret~rr. Freferabty the movet'o~ebeats~ ~ ~ ' ; . .
~,. ;y;, ~ . : : ; ~ : ; : . . .
'.S?:aad'8'JxA will~b~.ron's~rained byfZrst mid secand shautde~rs SS~A~..enc'i.Sg4~: ~
. ~_,. v ' : . . , . .... ,, , . . . . .
Yoo~nduit?~4,A trrsy ~ nurde of any type,of fle7cibte tubing (sucli~as ~m;cdical'.~'br other' . ~ 'y'., ~ ": ....'.. .~ .~,suc~ dew3iae.providing a sealod~passageway for t3~e flow of fluids, wlud~ may be pried, :~ ~ . ~ " ~ . '. , ~ .
'.' t' : . , . ~ . . . ' . ' i ~ '~ ~ .
. ~ '~ dr, out of s re~eervo'u of aay sort, , and vubiah prsferabiy csrr be diaposah'h wl lia$bla v ~ ~ ' ' . _ . ~' >
;:: ''': y<;.'., ~~'' . Ayr y ~ :' . ~.: g, '~ P~raxt Towed .Systeac , : . ~ .
: ; . ' ~ : , ' , . , .: ~ . , : ,, . ;. . . :.~~ , : :, y . ::, .
. ' IOOiI~, ~ ~ 'r'IG.. 3 T illu~dra~ tower system 2ltD0. Tower sy,~~00~~s ~th~ p~crnanex~t . ~ . ~ , . . ~ : .. ..
:. ~~.: ~~. , . ~ ~ ~ : w ~.e:, ~on'diaposablej pig of ha~rd~v~re fat reeves t~ various.d~nces of pri~o~s ldt ~ .
;. ' ~S'v ~ . ~ . ~ ~ ~ ~ : ' ~ . ~ ~ ' ~ ~ . 3 . . ' . . .
1000; ~vch ~aa cassette v 1.00, is~radiation ~hambcr'f0~, ~d c~trifr~,~
bow~;1!! (FhG ~ 1.). , . ~ .. ' . ' . ; > Tav~iar ~yst~.~fl0tl pex~r~ th~ waiving, tnui~, atut overall codt~l ~kt ~rrtve of fluid ~' , ~ ~ . . ' ..
. ~ ~ ' kit 1000. Tower ~ 2000 ~ ~ ~ . . ~ . .' ' , . . '. ...
' .~ ~'.S.,.i'1.:;..~.~h ~.~'. . . . . ' .
. ~~ f0~1. ~y 'fil'a'itg~'1 t~9 ~ of a ~SJhOp~' ~' . y GOI~TO~Ir~ ,~T 1~ a~ p~0~SB01 Ot ~~: ~~Ctli'L, COtlplet~ to 9~ of t$8 nab CO~. ' . , . . ..
ite a new! disposable .kit must be discarded atlxr each phmo'tophe~is. ~tlipy ',seesiaa~,~ lower . . ' .
,'.~.:~:~..;>.,;':_;w.. ~' ~ '.' ~ ' , ~ 3~ ' ~ . . :', ~ f ', ~ ., .~. :. .
..~ .~:~~ ,. ~..~,''r .;
' . . . . ' ~ ..:. ; ~ .. ' ,. ., . , .,., ..., . ;.;:y : v :~.', ,,:: _ ~'.;. . ;, ,;>,-. ',~ , ; ::. .' , :. ' : ~ ~ .,..:.~' .~' .~. ..~, .,;
,.;... ~: ,~.~ :~, , :.:,:.-; ,.y ~.:;~;:::.:..:...',:::~:
.v:~, .,'~ .':~ :' ~.~ ~. ~ ~ : ' : . ' ' . , ,: . ~.',.. ., . ~ : ., .. ,~ ,. . : S , , ' 4'~'~'; ..x i,~~.:'~..'~ . i . , ' ~ ' / ~ , ' ~: ...~ "; ,':,~,~'. "' ,:
~.::'; <,, ~ 1'~~ : :5 ".. ' - ~ . . , ~ ' ~ .. ' ~.'..., ~:. y,,..:~y'!
.-. :.,>~ '','. ~;~ ~''~.'.'~ . '. . . ' ' '. . ' Y , . . . ; ~ '. ~..: .'.
. '. vy~ :-,ay~t21100 is usod'.ovsr and ova~.ag~in. Tower sy~t~ ~ cant ~e roo.p~~~ :~ v ~ ~.
.~ 1~ . .:do~ei ofcorporeal blood circuit trestatea~, for exampie~a~i~r~iB;
Ziypropeziy ' . .
... . .' P~~ ller or by ds~s~ging some of ita comb: v ~ ~ ~ . - ~ ~ ' . : . .~ ~;
r . ~~ : ~: ~OQfl9~ ' ' Tower syst~am 2~90~ had a bou$i~ having an upper poraion Zand a bstne -'; pork 2~i0 lie portrQn 3,20E! has ~ top 1 and a bottain . ~2i?3~ . - ' ~ ~
. :provided at or tear ~ bottom ~t7~~ of base portion 2100 so tit s.20~ is mobile ~ - ~ - , .
.. -: ~d can~.easil be mo~red.i~oirc mom ~ room in a hospital sag...
Pbl~,~thevont . ~ : , : , ., : .
. ~ : , , , , .3.,, , ~ , : .~ wl~. ~3.~e.~ivotable about a vertical axis to allow ease ini ~.:g. ' - .
. ' , y , .
~~ ~~ fowe=~syst~ri.'Z000; ~ ~'op Z~OI of base pt~~un ??,04 hag a tap sut;~114:vaving ~co~ol ~ ' . ' .
-4,'.:; ~.
- .<i". ; : ~ . : ~ ' 1 . .. ,~~04; 'heat ilit~st~eid ~. PIG..?Z; built therein (see FiQ~.?2~: , in~
FILE. f'cesse~te 11'00 is. ' . . . : , .
~.'~ioaded~onto-ca~i ~~cdc ivo0. 8asepartion ZT,dD a3so'has lmbks (no~Ei~t~c'!~~ orot~r. : ~ . . . .
.. . : .. , . .
. ~ : . .contie~Ors; ~o haug pll~'sma coll~ctiori ba0 51 and trtent ba,0 ~1 ~orio.' hooks' ' ~ ' . ..
'. '~::.:.~,v.:~~:~: ~_::ca~ b~:tod~ anywh~ie on tower sym ~~0 so loit,~ as, their.pasi ' ~'izot ii~rfe~e .~: ' -: ~ ;~ -. . ~ .: . .~ y.
~ :a~it#~,d~ ~ictia~ry.of theayste~n d~rin~ th~tpy: lpor~io~n~0'hs~i p~toa~ivatiou .
. .'~,P'.~;. . . , ' ,: .cl~c 750 (FIG.1~8j located beldnui door ?5i. Additional hooks ~(~tot ili~ are ' , ' - . . ' ' ' ., , : . . . ~: .. . . ~
' -'' ~~ ' >; ~ .:.pin~dad: ova 'tower sy~-for l~n,~g saline aced antico~
ba~s.~ ~'a~l~, tt~e : . ...
,, : ~' . ~, yy. .: :'' ;. ' ~~; ; ~0'a ,, ~. i'o~ated. on, a ~ , onion ~ItfQ, v ~, ~ - : ~ , .. y :3, ~ .,. , _,~!... .l'P . ... ~ .:
;:[ott~tl~. ~ 1 Pl~otoac~ivation ear f~0 ~'ItC~ 18) is pravided'in base;
~loi~a 2200 0! ~~ .
- .v;° v '. ~' ; . . ., ; :.. : . : . . . . . , lxoar y51' is ' ' ' '.v~: ': :.: ~.btop ~Oi arid ~bottam izOZ door f~l~; - . . .
. . . .,,, . : - ~ ; . p ~ , ,,.. ~.... ..
. . . . ~ . : . . , ~ , - . ' . ~ ."'~yiva~bian v~ ~ ' . . . ~ , : ~
r ~, : ~ .:y ~ ~o.base arts 200 and as provided r aace~s , . .
,,~, % ,, , ~ :~, rlbe~. f~50 ~d ,to:a~ova the operator to dose photoactiv~tiota .f~0- so tl~ 'W lig~rt ~ :' : : .
. : ~o~s not' escape into ttie ~u~o~ during.treahx. less x~Z i~'~ pxovito allow tubes . . .
.. -. ° ' 11lZR iii? (FiGli .I ) .to pass.iato pho~vao~.v~~ chamber y~0 wvi~radiatio~ ~c~O ' . . ~ : . ~ ' .
. ~ . . ~.
~. ~ ~Io~ed .mid wc'~oor'~Sl is closed. T~~ photoa~ivation chbe~ .'is d~cussed ~ii~ detW . ~ . ~ '. ' . ' 'v ~ .; _ ~ ~ is ~ ~~ ~ ~ ' ~ ~ ~. . , , ., :.. , . . ~ ~ .,;..:.
. . . be~o~w with respect to FJtt~ 1 and , . . . ~ . . :~.. . - , :.
' . ~~. (p~l:~~j, UP~c portion ~IOO i~ loca~d ~tnp~ base pardon 3fi00..
Ceb~rifugs ~ . ' , . , v:'~lbl'~C~ a9~ is located in upper ~rtion 1100 beiiir~ ~chamb~' door Z10r2. ~
. ". .. ,' ~ ,..
.~ ...~' ~-' .~ '. ~ G~nuif~chaznber.door 2142 has d window 2103 so an operator caa se: ~n ce~rifuge ' ' ,:' ' ~ . ', ' ' , .
.. ::... '~ . box X101 and monitor for any problems. . Window X103 is' ci~i~wnh Mass thick ~ . , . ~:;; : :, : ': ~ . . ~ ~ . . . ~ ~ w. ' . ; . ~1 . : . ~ ~ , ,.
.~'~ .. ; '. enau~ to wilhstany.ariy forces that~~may be ~ted.aa~ it from an aceideat~lu~g. ' v c~t~ which fan xotats the ifu0e bowl at apecds o R~Ms.~ . . - . - . - :, ~ -. ' ..F~ ~. , ~ ~ ;' ' , ~
. ~~: :~ Pr~f, windew ~1,0~1 is co~~ of shatter-proof mss. 'lDooi~ ~107~ is hirigedly . ~. ~ , .
. ~ w: . ~ ~°' ~P'°r P~°n 2100 arid has an automatic locIGing. ;a~ecl~uairi, tlatt is'acdvated, by . ~ . . . . , ...:. :; :.... :.. . ... ., :: . . . . 3~ . .: . . :. :: .... . ... . . . ..
,: :.. . .: .. .
~ ' . ' ' . . ~ ' .: ; ~.: ' ~ . :~: ~ .. . : : ~ ..; _.:; , .,.. =v.: :; ;':
.~::;'~.' ;y ~ s;.w~
:, '::r, ' , ~,~ ~', ~ ' : ., ~, - . ~. ~ - ~ , '~ , ~ . , . , ' - , v..v . ' ~:: ~ ''; ~ : ~ .: ;.

. : :
., x .._ .
' .
'~ ' . ' . ~. ' ~ ' ' '' '' ~
~

'~.~..1.:~''. : .
; , ' .: .
x~ ~ '.;
I , ~ ~.'.:~~' .v'!'.
:'v '.':
. ~
~
... . . ~ . . ' ', . .

' : ;
: :~' :
'~ w'~ , , ~ _.
%~;.!': _ _ .
'~
_':
'..

. ' .
. .,. . , ~, . ..
, :
:.the holler dt~cin~ system oper~ion. Centrifuge chamber ~1~1 '~ ~~iscua~ed ''beiow ~' ~ ' ;..5:'.....1'~:: . ~ . '' ' '.1'~'',_:e. ..,~ ;.. . . ' , ..
I. . . ~,~:.;...W.
,;. ~ ire, dBtatl w~. tto 1~C~. Z9. , , . . ~,1~;
.' ~ '~ . ~ : .. ~

. .
:a.:; .
: .
~ . .
.; ,~api~j . ~ . Pref~ab~y, deck lad is located orr top surl~ce ~: o~"b~e; ~aitlon.~0o ~ ai. or , ~ ' , , ~~ erd from ~b~ ~ w .
'. .:: '~
,~;
~ , of ' tens ~O~or 2000 vvhf ie t~ppe~e pordun 3100 ~ ~e~t ~ . ' ~.
ir~r front sys . ~ u~w . ' : . , ay to , . .: , :.: ::.,;
~, '1~ ':: ~o'~'a, ~~; near tlae far aftower ~y~ttem ?.tIOQ.
. . 'Ibis allows the r :e~
;

' . , . , . _..: . ~ ~charnber : ' ;.,.. ~. .coil' deck Z~00 vvl~ile suvita'r~usl~ a~brdiztg s the opaator ass to ce~
. .. . .
!

, , .
. ' . xn theuppar , , ' , 'By d~si~n~ towidr system ~U to have t3~e cenfri~ge :' ~ c~abe~r ~ln.~
= ' ~L01, :i:':: . . . , , . . . ' , . '. ports 21x0, nod. the photoadtvation chmaiber ase poraon ~ . . , 1x00 i~t.~b . . .

.. 'I. ' .
.. ~?,Oti, .an tbit co~~uratton ~s ~.eved. As such,a redutced , , . . ' systctn tower a011It'has' ~ . . ' :: . r f 1e hos ' ~footpru~t side aa~d ts~OS: ug a educed aanout~t .
o vsiuab p~tai , " , :4;': s, ,' :. ~ ., ... : . . . . ' . . : ~~ Why . .
.8 .' y6f~!'yosvC'~ 2~ feal~S'b~O~V S17K'xy k~he~
SO '#i' OIIC view ~ llot Oti ~ ~

'fi ' . , . . ..
' : 's~ptt~e ~ arownd the hasg!ital~fo~a the teat,17~D0 . ' .
.4,dd~tlanally,'ba v~g deck ~

.. 1 ~' .in .a fairly horizontal, position w~'11 provitte ' '.~ 'the operator wiEh a plar~ toW t' ; ~d ' 'of , , . . . .
' ' ' .. , oad~.. Tower ' . ' :
~; kit ' ., . . .
101~0.duri:ig the loail~n,g~ofoi~rr devices, faalit~,ti~g easy~
'~

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. . . , . . ~ ,. ; . . ;' bY
sy~ata1100: is: robust' to wig forces and vibration' ught' on~
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~ : ':~ w:
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~ ~ A manitax 21114 ~ provided on c~~trifuge chambet,door:
ax0~ .
, X04. ~ , .
. above ,window ' . .

.. , ' . ~ '.
cl'to~: ~ opt', such onittar ~10~ bias a,displa~y area X103 for visuaily'displayin8' : ~1a3:''M

~

, , , . _ . :
, . , . '7. . ~~ ~~e~. .. ' ': t~; for.ex~inple, user inte!rtaces for dtry, loadsng in&t~u~onei, ~

' ~ ~ ~.PmB. nitor ~io4 is coi~aled to and. 0'1~ ~~ ~ ~$Ystem ~ '.: : ' ~ ~ . . . ': .:
,~ ' .
, .
,' a : . , . Zla4~W, c: .~ , . .
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- ~
.
' , con~ller. ~ A data cdCd reoaiving poiE a0tti is provided on ~ side~of ' . ~ed ~D 9~~~b~ ~elv0 i~8xa CSid ~.~~, WII~,C~! ftlp~l~l~ iVlt~l, ..
, ZS E ' .
~ : ; receiv~ port 2Q011s, pro _ ly . a , , . , ~ ~

. , :. , , : .1~ , ,. , , v' ; .~~~ p,~,is kit 100 (1~IC~.1); As m~tioued v~, ~ ~~i ~be . . . .
~,'= ~~ta irollei of tower' store serve a yeti o~ datn to supply to t~ s~te~ :
cod ;
':
prer~ t ~

, . : . , , . .. , . .
' ormetion'so~t~t . . . ' ~~p,.?i100. 3~or e?cample,.data surd 119 cart be,prag~amme~l to rei~yidf', .

i~ .comp~bl~ aiitli,, . , controll~r.c~n es~ue: r1~ that ~ di$poaabl~ photop~. ~ . _ .
:. lcit~ ~
. '.theaystem ~
..
~~~ ~~' :
.y: .- .. .. ., .: , ,: . ;
. , the':.blood drive equtpme~t mto ~avhich it . ' is beit~ laded; (2) that ~s'phaso ~, kit' $ . . ~ , .
: .

vi: . . . , v : - w, ~ : ~'~ophetes~s hit,is '' : capabl8 of r~iaa~in~ the des~ed '!dreatmmt pFOCees; . , (3) that 'the dssposabl~ pli .

.

~.' of.a,n:brand name or mates. Dcand'receivin~
part Z110~ '~s the s~eioessaty hardware' ' .
.
: : .

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' to both road data from, and wn~ dad ta, data ca~~
L~1.~9 ,5. , prefetati , data'card . . . .
~ ' ~ and ~rczut~

_ rt aZtti 1 record trt:>~py data to data card 1I9~5.
~~uch ii~foimatio~n ~ : ~ .
. p : ' . . .
v' ~ ' collection , ' cod voiumes, ',''tu~ volumetric : ~ ~ . : ' . .
rah' ii~cluc~~ far ale, tunes, .

, , . .: .'. ; . .: . . ~~~dis#urbas gin. theproc~s, , or any o,s3esired data, , . : . .
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t '~.'.~'~.;.~,~.'~f~.. 4 ,. w ' ' ~ : ' ''~'~~ ~.'~~ ~~, -._ ' ~ .; ' , ~:;y .' ;.. ~~
b ' ~ ~' ~ih ~d$~ G~Fd Fe~R1V11~ '~Qtt ~ 1~. pTOVi~d Oll ~(f~'~Or ~~,~s It ~
'be ~Ca~. ~~~ . ' ' . .
.- , : . . , . . ; ~ , ~ .. . . . .
'. ' ~~o~a ~ve~ ~ystetn'aQOO ~ ~o~ng as, it is caopled to tha sysbrnn con~rolF~r ax o'tbs~'~Spmp~te ; . ' . ~
.. .~:. ~~ . .~ ~ . . . , .:~ .. ~:. .: ',:i; ... . . : ~~ ~ ':.~. . .
:~~:':'~.~,,:'~;'~ :y-:ra. . ; ' ; ~ :.~' :w : v . ~,~:: ~ ,. w ~ v . ' :
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. . . . . ~ ~: A Pbotoact~va~on Chamber ~ R~ecelviug irrad'~ht .~ ~ ~ . ; ' ..
~ : . . .
.' ~ ~ ~ , ..
v '...:(p~~ . . Refenin$ tu~w to 1~'It~; is and t8y p~oac~ivd~aoaaber~'~5t1 ~is'illtl ; . . .
,_ . . :. ~ ~ : : . .: ~
' ~ ~u cross' s~.ion. P~otoactivation cbar 950~ is forn~ by bo .using 75&, ~s~.g'S6 5~ . . ~: . ~ .. '.
.. ~ . ~ , :with ba$e port~ton~2a0~ of tow~er~s~ b~iind doot'15i (F~. 1'7~.
~'bot~oactiVasian, ~ . ~ ~ , . : .
. . .caber 75b.hss ~a p~~ of ClectriCal conn~ctiori ~o?ts 953 pror~detl on b~3c wall'f~l. ', .' .
i...'. L :. ;,: :: . : . , . :a . ' ' . .
:~ : ~ - ; ,, f. ~~~ .~:. ~~ pn ports'~53 are electrii~ly coupled ~D a eoi~r of'~l~r"enet'gy. . , ' .
.;. :~ :v ''. ~ ~.Pi~o activation cls~mbeu 96~ is designed to receive UVA
light asshy' 7yIG, ~'1~6). ~ ., ~ .
t .
' . ~ ~ ~ ~ ' ~ ' ~ chamber 75t1 ' eiectricst c~ct(naE ~lus~ra~) . . 'When ~Ily;loaded~tt~o phv~tso~r s . ~ . , .':::r. . ~~:..lora~ed on cootsct walt:a~ of UVA light b~ X59 form ~
eiectric~' ~ ;~~~wi~,. ~ . . . , ei~' host pox#s 95~. , ~ Tl~s elf. connection alloww~ e~eGfiiic~al ~~nergy to be ' . , ~ v ~ ~ , ~ ''~ ~e Y ~. ~,. --~' ~' 1 ~: '. : ' . . ~ ° .. ' ' ' ' ' ~ ''i ' , .
_ . ' supp~ied'to~:INA lasnpa 958 so fat ttacy can be activ~ed:
t'rebl~!;:;Eb~s'~lec~ic~l ' . . ' . .. . .
'~~ .' a:'~aio~'.Provided for sek of t.1'VA la;nps'~:58. M~iaa.~bly, L1V'A
light ~ : :
'' s~~ ' ; ' - ~, ' ~ ~ ~ two ~, of W A tajmps ~~s forming a space wlcCh ~it~' .: ;: .~ ~. . ~ ' . . . .
' :1: 5w~ has . . . , , ' ~ . . : ' ; '. ' . , , ~.. . , ~.' . . ~~.
~ .,~ ;ins~ed.~ The s . of e~'ec~csl oner~~ to U'~A l~mmps .~$~ vs oor~o~lcd ~by the ~ . ' ~ ~ . ~ .
~; := ~::v~~~:'::'~v:-."~0... - ' ~P13' : . . , .,_: ,..;: .: . ~:: .. ~ :. ,.
, y~ .' .:.'...,..: .:.,,.:.
d. sham controller u~dng a swnt~.. UVA tsa~ps 7.58 ar~.acttv~ed aad. .
,:.jpropexly p~' ~!' . . . . . .i . . . ~ ~ .~ .
.. ..., ;aeaati~abed as necessary by'f~ cantrblier duri~ the photapheresis tb'Y'so~ ~ , : ~ ' ~ . .
~' v ,~~ ' , ' '~' ~ ~ ~ . videCt is the to of housi~'~ne~r.'bar,~c wsil~'154:
of . ~ . . . . .
. ~~ hole ~~S7 is ~o : ~ . p . ~ ~. .. . . .
":' , ~~ ',photo~ivation chamber fdtl. 'V~t lioie ~3~ c~nne~s towent ctt~t'7~1 wltiych~leet~ out'of ~ ~ ' . . ' ~ . ~.. ~
- .:.:.~. _ i; ~ ':v . ..~. back of tower s ~ ~, ~~ 2ao0. V~en he~'genere~ed by WA l~anps~1~8 . ~~b!~'ds np is ' ~, : ~ ' ~ ~ .. ~, ~.
,~ ; . , . , ~ . . ~ treat this bit e~~pe~ vation ~ ~ ' . . ~ . . ~
~~~phdtoa~ivatioa c'~SD a ~e~3'~ . , . . . .
. . ~ ' ~~.~le 78'~ v,~ di~ct'1~4. '1"be heat exits tower ~syst~m.2000 through , ' .
': ..:.,,.~ y~' ~, ~?.. .'': ~~' ::°c~mber.,'St1~Vla. . , . . , ' . , ., : . ;' . :. . , .'. ' '~ '. '. . ,., ..~:': ~ , _..
t, . ' ~ ~ i~g hole''~d.~. located ~ the rear of tower system Z00~, away &o~
~e p~snd , . ~ . ' n::::;'.~:.: )~~~ .-,:..'4 ~"~-'.:.~~~~"' . . ~ . , ' ,' 1 ~, ' . ': ..~, '~.;. . .. ., .. .. ~ .. ~: ..',.
. :r.'::., a . . " . . - . .
;:',...;', ', ;:~ :~ ''.':~:~,~atv~C.. ' ' . ' ~ '; . . . , . . .
'~ ~~i...~~f:~~". . .. , . , ~ , ~.: :a'; , ' ::: ,: ~0l~oa~v'~5t1 flcod 'a'~ ~!b~ fo~'recav~ng, , , , . . .
;. '' :~~~.:: .~,. ~ . .. , ~ ~ . ~ cisitii~'bnUV~~1~lacnps ' ' ~ ~ ' , . .
°.;.:,.,. 'f:, °,. ~ ~ . ;.'.,irk ~.~~. holdxrigarrsdia~on in are ttpp . . . ' ~ . .
, ~ .'y ~'7~8:,.'~.'~ta~t ~6~ is at~ora~oar the bottom ofphvatioa~chazn~er'~5t1. , .
,'a~l~lc . , ' . bes .. ~ . : ~ , y .',~,'chrcuit TG3'is ~~ovided belajw.tt~et y~ to doter~ any fluid lt~ics' ~ ~ Iit~ c :,'f ~'::;, ~ .. . ~F : .. . ' ~ ~ ' ' ~
',~p~ p1''$'' p~l'~Cal. l~oT W~CUIt ~~r tW0'~IIO ~d~'p8tt~l~ . ' '~ 'a . r ~ . . . , ~ ~. : ' "~ . ' ~ ~ ~ ~ ~ located .=m au adbeslv~ baclk~d flex circcuit. The e~,a~
d~i~ae~ tcWlow. . . , . . .
':°:i!y.'.'..v::'..;~1~~,.,y:'.my~~s. . v ' 1 : , . . ; , .' , . ' . ' ~ .;.: ~: :~ .v,.
;''~~ ''. :' ' .:i: .~ '..-.. '' ; ' . . . , : . . ' . : . 41 . ' ~ , . .. , '; . ' ' ,' . ~ ., . v,'.'. .' :. , ; y,:
W.. .. ' . . . . .';' - . a ' . ,;~ . '' . : ' . . . ' ' .y'. . , ;: w : ,~,' ,, ~ '' . . . ~. ~' ' ' . ' . :,.; c~.~ . ~ ' ' .... ..;.;..' ..;':...'..,' ..;
~.,;'.:::

for application of a short circuit to test for discontinuities. One end of each electrode goes to an integrated circuit while the other end of each electrode is tied to a solid-state switch: The solid-state switch can be used to check for continuity of the electrodes. By closing the switch the electrodes are shorted to one another. The integrated circuit then detects the short.
Closing the switch causes a situation equivalent to the electrodes getting wet (i.e., a leak). IN
If the electrodes are damaged in any way, the continuity check will fail. This is a positive indication that the electrodes are not damaged. This test can be performed each time at system start-up or periodically during normal operation to ensure that leak detection circuit 762 is working properly. Leak detection circuit 762 helps ensure that leaks do not go unnoticed during an entire therapy session because the leak detection circuit is damaged. An electrical schematic of leak detector circuit 762 is provided in FIG. 20.
B. Centrifuge Chamber (00127) FIG. 19 illustrates centrifuge chamber 2101 in cross section with the housing of tower system 2000 removed. Rotational device 900 (also in cross-section) capable of utilizing I-omega 2-omega spin technology is positioned within centrifuge chamber 2101.
Rotational device 900 includes a rotating bracket 97 0 and a bowl holding plate 919 for rotatably securing centrifuge bowl 10 (FIG. 1). Housing 2107 of centrifuge chamber 2101 is preferably made of aluminum or some other lightweight, sturdy metal.
Alternatively, other rotational systems may be used within tower system 2000 such as that described in U.S.
Patent No. 3,986,442, which is expressly incorporated herein by reference in its entirety.
j00128] Leak detection circuit 2106 is provided on back wall 2i 08 of housing 210?.
Leak detection circuit 2106 is provided to detect any leaks within centrifuge bowl 10 or the connecting tubes during processing. Leak detection circuit 2106 is identical to leak detector circuit 762 described above. An electrical schematic of leak detection circuit 2106 is provided in FIG. 21.
C. Fluid Flow Control Deck [00129] FIG. 22 illustrates control deck 1200 of tower system 2000 (FIG. 17) without a cassette 1100 loaded thereon. Control deck 1200 performs the valuing and pumping so as to drive and control fluid flow throughout photopheresis kit 1000. Preferably, deck 1200 is a separate plate 1202 that is secured to base portion 2200 of tower system 2000 via screws or other securing means, such.as, for example, bolts, nuts, or clamps. Plate 1202 can be made of steel, aluminum, or other durable metal or material.
(00130] Deck 1200 has five peristaltic pumps, whole blood pump 1301, return pump 1302, recirculation pump 1303, anticoagulant pump 1304, and red blood cell pump 1305 extending through plate 1202. Pumps 1301-1305 are arranged on plate 1202 so that when cassette 1100 is loaded onto deck 1200 for operation, pump loop tubes 1120-1124 extend over and around pumps 1301-1305 (FIG. 25).
(00131] Air bubble sensor assembly 1204 and HCT sensor assembly 1205 are provided on plate 1202. Air bubble sensor assembly 1204 has three trenches 1206 for receiving tubes 1114,1106, and 1119 (FIG. 25). Air bubble sensor assembly 1204 uses ultrasonic energy to monitor tubes 1114,1106, and 1119 for differences in density that would indicate the presence of air in the liquid fluids normally passing therethrough. Tubes 1 114,1106, and 1119 are monitored because these lines go to the patient. Air bubble sensor assembly 1204 is operably coupled and transmits data to the system controller for analysis. If an air bubble is detected, the system controller will shut down operation and prohibit fluid flow into the patient by occluding tubes 1114, 1106, and 1109 by moving compression actuators 1240-1242 to a raised position, thereby compressing tubes 1114,1106, and 1119 against cassette 1100 as discussed above and/or shutting down the appropriate pump. HCT sensor assembly 1205 has trench 1207 for receiving HCT component 1125 of tube 1116. HCT sensor assembly 1245 monitors tube 1116 for the presence of red blood cells by using a photoelectric sensor. HCT sensor assembly 1205 is also operably coupled to and transmits data to the system controller. Upon HCT sensor assembly 1205 detecting the presence of red blood cells in tube 1116, the system controller will take the appropriate action, such as stopping the appropriate pump or activating one of compression actuators 1243-1247, to stop fluid flow through tube 1116.
(00132] Deck 1200 also has five compression actuators 1243-1247 and three compression actuators 1240-1242 strategically positioned on plate 1202 so that when cassette 1100 is loaded onto deck 1200 for operation, each of compression actuators 1240-1247 are aligned with corresponding apertures 1137 and 1157. Compression actuators 1240-1247 can be moved between a lowered position and a raised position. As illustrated in FIG. 22, compression actuators 1243-1247 are in the lowered position and compression actuators 1240-1242 are in the raised position. When in a raised position, and when cassette II00 is loaded onto deck 1200 as illustrated in FIG 25, compression actuators 1240-1247 will extend through the corresponding apertures 1137 or 1157 and compress the portion of flexible tubing that is aligned with that aperture, thereby pinching the flexible tube shut so that fluid can not pass. When in the lowered position, compression actuators 1240-1247 do not extend through apertures 1137 and 1157 and thus do compress the flexible tubing.
(00133] Compression actuators 1243-1247 are spring retracted so that their default position is to move to the lowered position unless activated. Compression actuators 1243-1247 are independently controlled and can be raised r lowered independent of one another.
Compression actuators 1240-1242 on the other hand are coupled together. As such, when one compression actuator 1240-1242 is lowered or raised, the other two compression actuators 1240-1242 are also lowered in raised accordingly. Additionally, compression actuators 1240-1242 are spring loaded so that their default position is to move to the raised position. Thus, if the system loses power during a therapy session, compression actuators 1240-1242 will automatically move to the raised position, occluding tubes 1114, 1106, and

11,19 and preventing fluids from entering or leaving the patient.
(00134] Referring now to FIGS. 23 and 24, deck 1200 further includes system controller 12IO, cylinder assembly 1211, manifold assemblies 1213, pump cable 1215, pump motor cable 1216, and timing belt assembly 1217. System controller 1210 is a properly programmed integrated circuit that is operably coupled to the necessary components of the system to perform all of the functions, interactions, decisions, and reaction discussed above and necessary to perform a photopheresis therapy according to the present invention.
Cylinder assembly 1211 couples each of compression actuators 1240-1247 to a pneumatic cylinder. Air ports 1212 are provided on the various elements of deck 12Q0 as necessary to connect air lines to the devices and the appropriate one of manifolds 1213. As such, air can be provided to the devices as necessary to actuate the necessary component, such as compression valves 1240-1247. All of these functions and timing are controlled by system controller 1210. Timing belt assembly 1217 is used to coordinate the rotation of rotating clamps 1203. Finally, plate 1202 includes a plurality of holes 1215, 1219,1220,1221, and 1218 so that the various components of deck 1200 can be properly loaded into and so that deck 1200 can be secured to tower system 2000. Specifically, pumps 1301-1305 fit into holes 1314, HCT sensor assembly 1205 fits into hole 1220, air bubble detector assembly 1204 f is into hole 1219, compression actuators 1240-1247 extend through holes 1218, and bolts extend through holes 1221 to secure deck 1200 to tower assembly 2000.

1. Cassette. Clamping Mechanism [00135] Referring now to FIGS. 22 and 25, the method by which cassette 1100 is loaded and secured to deck 1200 will now be discussed. In order for system 2000 to perform a photopheresis therapy, cassette 1100 must be properly loaded onto deck 1200.
Because of the compression actuator valuing system incorporated in the present invention, it is imperative that cassette 1100 be properly secured to deck 1200 and not shift or become dislodged when compression actuators 1240-1247 occlude portions of the flexible tubing by compressing the flexible tubing against cover 1130 of cassette 1100 (FIG. 3).
However, this requirement competes with the desired goals of ease in loading cassette 1100 onto deck 1200 and reducing operator errors. All of these goals are achieved by the below described cassette clamping mechanism.
[00136] In order to facilitate clamping of cassette 1100 to deck 1200, deck 1200 is provided with two catches 1208 and two rotating clamps 1203 and 1223. Catches 1208 have a slot 1228 near the middle of the top plate. Catches 1208 are secured to plate 1202 at predetermined positions so that the spacing between them is substantially the same as the spacing between tabs 1102 and 1103 on cassette 1100 (FIG. 2). Rotating clamps 1203 and 1223 are illustrated in a closed position. However, rotating clamps 1203 and 1223 can be rotated to an open position (not illustrated) manually or through the automatic actuation of a pneumatic cylinder. Rotating clamps 1203 and 1223 are spring loaded by torque springs so as to automatically return to the closed position when additional torque is not being applied.
Rotating clamps 1203 and 1223 are linked together by timing belt assembly 1217 (FIG. 24).
[00137] Referring now to FIG. 23, timing belt assembly 1217 comprises timing belt 1226, torque spring housings 1224, and tension assembly 1225. Timing belt assembly 1217 coordinates the rotation of rotational clamps 1203 and 1223 so that if one is rotated, the other also rotates in the same direction and the same amount. In other words, rotational clamps 1203 and 1223 are coupled. Tension assembly 1217 ensures that timing belt 1226 is under sufficient tension to engage and rotate the rotational clamp 1203 or 1223 that is being coordinated. Torque spring housings 1224 provide casings for the torque springs that torque rotational clamps 1203 and 1223 to the closed position.
[00138) Refernng back to FIGS. 22 and 25, when loading cassette 1100 onto deck 1200, cassette 1100 is placed at an angle to deck 1200 and tabs 1102 and 1103 (FIG. 2) are aligned with catches 1208. Cassette 1100 is moved so that tabs 1102 and 1103 slidably insert into catches 1208. Rotational clamps 1203 and 1223 are in the closed position at this time.

The rear of the cassette 1100 (i.e. the side opposite the tabs 1102 and 1103) contacts rotational clamps 1203 and 1223 as tabs 1102 and 1103 axe being inserted in catches 1108.
As force is applied downward on cassette 1100, rotational clamps 1103 and 1123 will be rotated to the open position, allowing the rear of cassette 1100 to move downward to a , position below ledges 1231 of rotational clamps 1203 and 1223. Once cassette 1100 is in this position, the rotational clamps 1203 and 1223 spring back from the force applied by the torque springs and rotate back to the closed position, locking cassette 1100 in place. When in the locked position, cassette 1100 can resist upward and lateral forces.
[00139] To remove cassette 1110 after the therapy session is complete, rotational clamps 1203 and 1223 are rotated to the open position either manually or automatically.
Automatic rotation is facilitated by an air cylinder that is coupled to an air line and system controller 1210. Once rotational clamps 1203 and 1223 are ire the open position, cassette 1100 is removed by simple lifting and sliding tabs 1102 and 1103 out of catches 1208. .
2. Self Loading Peristaltic Pumps [00140] Referring to FIG. 24, peristaltic pumps 1301-1305 are provided on deck and are used to drive fluids through photopheresis kit 1000 (FIG. 1) along desired pathways.
The activation, deactivation, timing, speed, coordination, and all other functions of peristaltic pumps 1301-1305 are controlled by system controller 1210. Peristaltic pumps 1301-1305 are identical in structure. However, the placement of each peristaltic pump 1301-1305 on deck 1200 dictates the function of each peristaltic pump 1301-1305 with respect to which fluid is being driven and along which pathway. This is because the placement of peristaltic pumps 1301-1305 dictates which pump loop 1220-1224 will be loaded therein.
[00141] Referring now to FIGS. 28 and 29, whole blood pump 1301 is illustrated in detail. The structure and functioning of whole blood pump will be described with the understanding that peristaltic pumps 1302-1305 are identical. Whole blood pump 1301 has motor 1310, position sensor 1311, pneumatic cylinder 1312, pneumatic actuator 1313, rotor 1314 (best illustrated in FIG. 30), and housing 1315.
[00142] Rotor 1314 is rotatably mounted within housing 1315 and is in operable connection with drive shaft 1316 of motor 1310. Specifically, rotor 1314 is mounted within curved wall 1317 of housing 1315 so as to be rotatable by motor 1310 about axis A-A. When rotor 1314 is mounted in housing 1315, a space 1318 exists between rotor 1314 and curved wall 1317. This space 1318 is the tube pumping region of whole blood pump 1301 into which pump loop tube 1121. .(FIG. 33) fits when loaded for pumping. Position sensor 1316 is coupled to drive shaft 1316 of motor 1310 so that the rotational position of rotor 1314 can be monitored by monitoring drive shaft 1316. Position sensor 1311 is operably connected and transmits data to system controller 1210 (FIG. 24). By analyzing this data, system controller 1210, which is also coupled to motor 1310, can activate motor 1310 to place rotor 1314 in any desired rotational position.
[00143) Housing 1315 also includes a housing flange 13x9. Housing flange 1319 is used to secure whole blood pump 1310 to plate 1202 of deck 1200 (FIG. 22).
More specifically, a bolt is extended through bolt holes 1320 ofhousing flange 1319 to threadily engage holes within plate 1202. Housing flange 1319 also includes a hole (not shown) to allow pneumatic actuator 1313 to extend therethxough. This hole is sized so that pneumatic actuator 1313 can move between a raised and lowered position without considerable resistance. Pneumatic actuator 1313 is activated and deactivated by pneumatic cylinder 1312 in a piston-like manner through the use of air. Pneumatic cylinder 1312 comprises air inlet .
hole 1321 for connecting an air supply line. When air is supplied to pneumatic cylinder 1312, pneumatic actuator extends upward through housing flange 1319 to a raised position.
When air ceases to be supplied to pneumatic cylinder 1312, pneumatic actuator retracts back into pneumatic cylinder 1312, returning to the lowered position. System controller 1210 (FIG. 22) controls the supply of air to air inlet hole 1321.
[00144] Curved wall 1317 of housing 1315 contains two slots 1322 (only one visible).
Slots 1322 are located on substantially opposing sides of curved wall 1317.
Slots 1322 are provided for allowing pump loop tube 1121 (FIG. 33) to pass into tube pumping region 1318.
More specifically, pump inlet portion 1150 and outlet portions 1151 (FIG. 33) of pump loop tube 1121 pass through slots 1322.
[00145] Turning now to FIGS. 30 and 31, rotor 1314 is illustrated as removed from housing 1315 so that its components are more clearly visible. Rotor 1314 has a top surface 1323, angled guide 1324, rotor flange 1325, two guide rollers 1326, two drive rollers 1327, and rotor floor 1328. Guide rollers 1326 and drive rollers 1327 are rotatably secured about cores 1330 between rotor floor 1328 and a bottom surface 1329 of rotor flange 1325. As is best illustrated in FIG. 29, cores 1330 fit into holes 1331 of rotor floor 1328 and recesses 1332 in bottom surface 1329. Guide rollers 1326 and drive rollers 1327 fit around cores 1330 and can rotate thereabout. Preferably, two guide rollers 1326 and two drive rollers 1327 are provided. More preferably, guide rollers 1326 and drive rollers 1327 are provided on rotor 13I4 so as to be in an alternating pattern.
(00146] Referring to FIGS. 29 and 31, drive rollers 1327 are provided to compress the portion of pump loop tube 1121 that is loaded into tube pumping region 1318 against the inside of curved wall 1317 as rotor 1314 rotates about axis A-A, tloereby deforming the tube and forcing fluids to flow through the tube. Changing the rotational speed of rotor 1314 will correspondingly change the rate of fluid flow through the tube. Guide rollers 1326 are provided to keep the portion of pump loop tube 1121 that is loaded into tube pumping region 1318 properly aligned during pumping. Additionally, guide rollers 1326 help to properly load pump tube loop 1121 into tube pumping region 1318. While guide rollers 1326 are illustrated as having a uniform cross-section, it is preferred that the top plate of the guide rollers be tapered so as to come to a sharper edge near its outer diameter.
Tapering the top plate results in a guide roller with a non-symmetric cross-sectional profile.
The tapered embodiment helps ensure proper loading of the tubing into the tube pumping region.
(00147] Rotor 1314 further includes cavity 1328 extending through its center.
Cavity 1328 is designed to connect rotor 1314 to drive shaft 1316 of motor 1310.
[00148] Referring now to FIGS. 30 and 32, rotor flange has opening 1333.
Opening 1333 is defined by a leading edge 1334 and a trailing edge 1335. The terms leading and trailing are used assuming that rotating rotor 1314 in the clockwise direction is the forward direction while rotating rotor 1314 in a counterclockwise direction is the rearward direction.
However, the invention is not so limited and can be modified for counterclockwise pumps.
Leading edge 1334 is beveled downward into opening 1333. Trailing edge 1335 extends upward from the top surface of rotor flange 1325 higher than the leading edge 1334. Leading edge is provide for trailing edge for capturing and feeding pump loop tube 1121 into tube pumping region 1318 upon rotor 1314 being rotated in the forward direction.
[OOI49] Rotor 1314 also has angled guide 1324 extending upward, at an inverted angle, from rotor flange 1325. Angled guide 1324 is provided for displacing pump loop tube 1121 toward rotor flange 1325 upon rotor 1314 being rotated in the forward direction.
Preferably, angled guide 1324 has elevated ridge 1336 running along top surface 1323 for manual engagement by an operator if necessary. More preferably, angled guide 1314 is located forward of leading edge 1334.
[OOI50] Referring now to FIGS. 28 and 33, whole blood pump 1301 can automatically load and unload pump lop tube 1121 into and out of tube pumping region 1318.
Using as position sensor 1311, rotor.1314 is rotated to a loading position where angled guide 1324 will face cassette 1100 when cassette 1100 is loaded onto deck 1200 (FIG. 25). More specifically, rotor 1314 is preset in a position so that angled guide 1324 is located between inlet portion 1150 and outlet portion 1151 of pump loop 1121 when cassette 1100 is secured to the deck, as is illustrated in FIG. 13. When cassette 1100 is secured to deck 1200, pump lop tube 1121 extends over and around rotor 1314. Pneumatic actuator 1313 is in the lowered position at this time.
[00151] Once cassette 1100 is properly secured and the system is ready, rotor 1314 is rotated in the clockwise direction (i.e., the forward direction). As rotor 1314 rotates, pump tube loop 1121 is contacted by angled guide 1324 and displaces against the top surface of rotor flange 1325. The portions of pump loop tube 1121 that are displaced against rotor flange 1325 are then contacted by trailing edge 1325 and fed downward into tube pumping region 3318 through opening 1333. A guide roller 1326 is provided directly after opening 1333 to further properly position the tubing within tube pumping chamber for pumping by.
drive rollers 1327. When loaded, inlet portion 1150 and outlet portion 1151 of pump loop tube 1121 pass through slots 1322 of curved wall 1317. One and a half revolutions are needed to fully load the tubing.
[00152] To automatically unload pump tube loop 1121 from whole blood pump 1301 after the therapy is complete, rotor 1314 is rotated to a position where opening 1333 is aligned with the slot 1322 through which outlet portion 1151 passes. Once aligned, pneumatic actuator 1313 is activated and extended to the raised position, contacting and lifting outlet portion 1151 to a height above trailing edge 1335. Rotor 1314 is then rotated in the counterclockwise direction, causing trailing edge to 1335 to contact and remove pump loop tube 1121 from tube pumping region 1318 via opening 1333.
D. Infra-Red Communication [00153] Referring to FIG. 34, tower system 2000 (FIG. 17) preferably further includes a wireless infrared ("IR") communication interface (not shown). The wireless IR interface consists of three primary elements, system controller 1210, IRDA protocol integrated circuit, 1381, and IfRDA transceiver port 1382. The IR communication interface is capable of both transmitting and receiving data via IR signals from a remote computer or other device having IR capabilities. In sending data, system controller 1210 sends serial communication data to the IRDA protocol chip 1381 to buff the data. IRDA protocol chip 1381 adds additional data and other communication information to the transmit string and then sends it to IRDA
transceiver 1382. Transceiver 1382 converts the electrical transmit data into encoded light pulses and transmits them to a remote device via a photo transmitter.
[00154] In receiving data, IR data pulses are received by a photo detector located on the transceiver chip 1382. The transceiver chip 1382 converts the optical light pulses to electrical data and sends the data stream to IRDA protocol chip 1381 where the electrical signal is stripped of control and additional IRDA protocol content. The remaining data is then sent to the system controller 1210 where the data stream is parsed per the communication protocol.
(00155] By incorporating an IR communication interface on tower system 2000 real time data relating to a therapy session can be transmitted to a remote device for recording, analysis, or further transmission. Data can be sent via IR signals to tower system 2000 to control the therapy or allow protocols to be changed in a blinded state.
Additionally, IIt signals do not interfere with other hospital equipment, like other wireless transmission methods, such as radio frequency.
III. Photopheresis Treatment Process (00156] Referring together to Fig. 26, a flow chart illustrating an embodiment of the invention which includes photactivation of huffy coat, and Fig. 27, a schematic representation of apparatus which can be employed in such an embodiment, the process starts 1400 with a patient 600 connected by means of a needle adapter 1193 carrying a needle, for drawing blood, and needle adapter 1194 carrying another needle, for returning treated blood and other fragments. Saline bag 55 is connected by connector 1190 and anticoagulant bag 54 is connected by connector 1191. Actuators 1240, 1241, and 1242 axe opened, anticoagulant pump 1304 is turned an, and saline actuator 1246 is opened so that the entire disposable tubing set is primed 1401 with saline SS and anticoagulant 54. The centrifuge 10 is turned on 1402, and blood-anticoagulant mixture is pumped 1403 to the centrifuge bowl 10, with the A/C pump 1304 and WB pump 1301 controlled at a 1:10 speed ratio.
(OOI57] When the collected volume reaches 150 ml 1404, the return pump 1302 is set 1405 at the collection pump 1301 speed until red cells are detected 1406 at an HCT sensor (not shown) in the centrifuge chamber 1201 (Fig. 19). Packed red cells and huffy coat have at this point accumulated in the spinning centrifuge bowl and are pumped out slowly at a rate, controlled by the processor, which maintains the red cell line at the sensor interface level.
so (00158) The red cell.pump 1305 is then set 1407 at 35% of the inlet pump speed while controlling 1408 the rate to maintain the cell line at the interface level until the collection cycle volume is reached 1409, at which point the red cell pump 1305 is turned off 1410 and the fluid path to the treatment bag 5m via the HCT sensor 1125 is opened by lowering actuator 1244, and stops when the HCT sensor 1125 detects 1411 red cells.
"Collection cycle volume" is defined as the whole blood processed target divided by the number of collection cycles, for example a white blood process target of 1500 ml may require 6 cycles, and so 1500/6 is a volume of 250 ml. With whole blood continuing a~t 1410 to be delivered from the patient to the bowl and the red cell pump off, red cells will accumulate and will push out the huffy coat from inside the bowl 10. The red cells are used to push out the huffy coat and will be detected by the effluent hematocrit (HCT) sensor, indicating that the huffy coat has been collected.
(00159] If another cycle is needed 1412, the centrifuge 10 effluent path is returned 1413 to the plasma bag 51 and the red cell pump 1305 rate is increased 1413 to the inlet pump 1301 pump rate until red cells are detected 1414, which is the begirnzing of the second cycle. If another cycle 1412 is not needed, the centrifuge 10 is turned off 1415 and inlet pump 1301 and anticoagulant pump 1304 are set at KVO rate, 10 ml/hr in this embodiment.
The effluent path is directed 1416 to the plasma bag 51, the red cell pump 1305 rate is set 1417 at 75 mI/min, the recirculation pump 1303 and photoactivation lamps are turned on 1418 for sufficient period to treat the huffy coat, calculated by the controller depending on the volume and type of disease being treated.
[00160] When the bowl IO is empty 1419, the red cell, pump 1305 is turned off and the plasma bag 51 is emptied 1421 by opening actuator 1247 and continuing return pump 1302. The return pump 1302 is tamed off I42Z when the plasma bag 51 is empty and when photoactivation is complete 1423, the treated cells are returned 1424 to the patient from the plate 700 by means of the return pump 1302. Saline is used to rinse the system and the rinse is returned to the patient, completing the process 1425.
(00161] The anticoagulant, blood from patient, and fluid back to patient are all monitored by air detectors 1204 and 1202, and the fluid back to the patient goes through drip chamber and filter 1500. The pumps, 1304, 1301, 1302, 1303, and 1305, the actuators 1240, 1241, 1242, 1243, 1244, 1245, 1246, and 1247, and the spinning of the bowl 10 are all controlled by the programmed processor in the tower.
si [00162) The process and related apparatus have significant advantages over prior processes and apparatus in that the invention allow huffy coat to be in the bowl longer since red cells are being drawn off while collecting huffy coat in the bowl while centrifuging, keeping more huffy coat in the bowl until the desired amount of huffy coat cells are collected prior to withdrawing the collected huffy cells. Platelets, leukocytes, and other huffy coat fractions can also be separated, or red cells can be collected rather than returning them with plasma to the patient as the illustrated process does.
[00163] It has been found that increasing the time that huffy coat 810 is subjected to rotational motion in centrifuge bowl 10 yields a "cleaner cut" of huffy coat 820. A "cleaner cut" means that the hematocrit count (HCT%) is decreased. HCT% is the amount of red blood cells present per volume of huffy coat. The amount of time that huffy coat 820 is subjected to rotational motion in centrifuge bowl 10 can be maximized in the following manner. First, whole blood 800 is fed into first bowl channel 420 as centrifuge bowl 10 is rotating. As discussed above, whole blood 800 is separated into huffy coat 820 and RBC's 810 as it moves outwardly atop lower plate 300. Second bowl channel 410 and third bowl channel 740 are closed at this time. The inflow of whole blood 800 is continued until the separation volume 220 is filled with a combination of huffy coat 820 near the top and RBC's 810 near the bottom of centrifuge bowl 10. By removing RBC's 810 from centrifuge bowl via second bowl channel 410 only, additional volume is created for the inflow of whole blood 800 and the unremoved huffy coat 820 is subjected to rotational forces for an extended period of time. As centrifuge bowl 10 continues to rotate, some of the ItBC's 810 that may be trapped in huffy coat 820 get pulled to the bottom of centrifuge bowl 10 and away from third bowl channel 740 and huffy coat 820. Thus, when third bowl channel 740 is opened, the huffy coat 820 that is removed has a lower HCT%. By controlling the inflow rate of whole blood 800 and the outflow rates of huffy coat 820 and RBC's 810, a steady state can be reached that yields a huffy coat 820 with an approximately constant HCT%.
[00164) The elimination of batch processing and the improved yields achieved by the current invention, have reduced the treatment time necessary to properly treat patients. For an average sized adult, 90-100 milliliters of huffy coat/white blood cells must be captured in order to conduct a full photopheresis treatment. In order to collect this amount of huffy coat/white blood cells, the present invention needs to process around 1.5 liters of whole blood. The required amount of huffy coat/white blood cells can be removed from the 1.5 liters of whole blood in about 30-45 minutes using the present invention, collecting around 60% or more of the total amount of the huffy coatJwhite blood cells that are subjected to the separation process. The captured huffy coat/white blood cells have an HCT of 2% or less. In comparison, one existing apparatus, the UVAR XTS, takes around 90 minutes to process 1.5 liters of whole blood to obtain the sufficient amount of huffy coat/white blood cells. The UVAR XTS only collects around 50% of the total amount of the huffy coat/white blood cells that are subjected to the separation process. The HCT of the huffy coat/white blood cells collected by the UVAR XTS is around, but not substantially below, 2%. Another existing apparatus, the Cobe Spectra' by Gambro, must process 10 liters of whole blood in order to collect the sufficient amount of huffy coatlwhite blood cells. This typically takes around 150 minutes, collecting only 10-15% of the total amount of the huffy coat/white blood cells that are subjected to the separation process, and having an HCT of about 2%. Thus, it has been discovered that while existing apparatus and systems require anywhere from 152 to 225 minutes to separate, process, treat, and reinfiase the requisite amount of white blood cells or huffy coat, the present invention can perform the same functions in less than 70 minutes.
These times do not include the patient preparation or prime time. The times indicate only the total time that the patient is connected to the system.

Claims (36)

1. A method of collecting a desired blood component comprising:
providing a separator having an inlet, a first outlet, and a second outlet;
drawing whole blood from a source;
adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;
pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate;
separating the mixture into blood components of different densities;
withdrawing plasma and red blood cells from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and red blood cells being withdrawn at rates so as to build up buffy coat in the separator, the plasma being withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet; and upon a predetermined amount of buffy coat building up in the separator, collecting the buffy coat from the separator.

2. The method of claim 1 wherein the step of collecting the buffy coat from the separator comprises discontinuing the withdrawal of red blood cells from the second outlet, thereby causing the red blood cells to push the buffy coat out of the separator via the first outlet:

3. The method of claim 2 further comprising collecting the withdrawn buffy coat in a treatment bag.

4. The method of claim 2 further comprising discontinuing the collecting of buffy coat when red blood cells are detected in an outlet line fluidly connected to the first outlet.

5. The method of claim 1 wherein the step of withdrawing plasma and red blood cells from the separator comprises: withdrawing only the plasma from the separator via the first outlet until a predetermined amount of red blood cells are detected in the separator;
and upon the predetermined amount of red blood cells being detected in the separator, withdrawing red blood cells from the separator at a rate so as to maintain the amount of red blood cells present in the separator at approximately the predetermined amount.

6. The method of claim 5 wherein the predetermined amount of red blood cells is detected using a hematocrit sensor.

7. The method of claim 1 further comprising: collecting the withdrawn plasma in a plasma storage bag; mixing the withdrawn plasma with a priming fluid; and upon a selected amount of plasma being collected in the plasma storage bag, returning the mixture of plasma and priming fluid to the source.

8. The method of claim 7 further comprising mixing the withdrawn red blood cells with the plasma and priming fluid mixture from the plasma collection bag and returning the red blood cells-plasma-priming fluid mixture to the source at a rate approximately equal to the inlet rate.

9. The method of claim 1 wherein the step of pumping the mixture into the separator comprises passing the mixture through a cassette for controlling fluid flow before the mixture enters the separator.

10. The method of claim 1 further comprising: injecting a photoactivation chemical into the collected buffy coat; and irradiating the collected buffy coat within an irradiation chamber until a predetermined amount of energy has been transferred to the collected buffy coat.

11. The method of claim 10 wherein the step of irradiating the buffy coat comprises recirculating the collected buffy coat between a treatment bag and the irradiation chamber.

12. The method of claim 10 further comprising: passing the irradiated buffy coat through a filter; and returning the irradiated buffy coat to the source.

13. The method of claim 12 wherein overall treatment time is less than about 70 minutes.

14. The method of claim 13 wherein the overall treatment time is less than about 45 minutes.

15. The method of claim 12 wherein the filter is within a cassette for controlling fluid flow.

16. The method of claim 1 further comprising collecting the withdraw red blood cells.

17. The method of claim 1 wherein the source is a patient, a whole blood storage bag, or. a blood donor, and wherein the separator is a centrifuge bowl.

18. A method of collecting a desired blood component comprising:
withdrawing whole blood from a patient;
combining anticoagulant with the whole blood at a selected ratio of anticoagulant to whole blood;
pumping the combination of whole blood and anticoagulant through a fluid flow controller to a separator;
operating the separator until air is displaced;
continuing to pump the combined whole blood and anticoagulant into the separator and collecting separated plasma until a selected amount of plasma is collected;
mixing plasma with a priming fluid and returning the mixture of plasma and priming fluid to the patient at the same rate as incoming whole blood until red blood cells are detected;
withdrawing red cells and pumping at a speed controlled so as to maintain a red cell line selected level in the separator while collecting buffy coat in the separator;
at a selected time, when a desired amount of buffy coat cells are collected in the separator, continuing to pump whole blood into the separator while discontinuing pumping red blood cells, thereby causing the red blood cells to push buffy coat out of the separator until a desired amount is collected in a buffy coat collector;
discontinuing collection of buffy coat when red blood cells have been detected.

19. The method of claim 18 further comprising:

mixing the withdrawn red blood cells with plasma from the plasma collection bag and returning the mixture to the patient;
pumping buffy coat to a treatment bag;
injecting photoactivation chemical into the buffy coat in the treatment bag;
pumping the buffy coat and photoactivation chemical mixture from the treatment bag to an irradiation chamber;
recirculating the buffy coat between the treatment bag and the irradiation chamber;
irradiating the buffy coat in the irradiation chamber while recirculating;
pumping the irradiated buffy coat from the irradiation chamber to the treatment bag;
pumping irradiated buffy coat from the treatment bag through a filter in the controller and then back to the patient.

20. The method of claim 19 wherein the priming fluid is a mixture of anticoagulant and saline.

21. The method of claim 19 wherein the fluid flow controller is a cassette, wherein the separator is a centrifuge bowl, wherein the air is displaced into a plasma bag, wherein red blood cells are detected at a bowl sensor, wherein the red blood cell line is detected at a sensor interface.

22. The method of claim 19 wherein the buffy coat cells are separated and one or more selected components are collected, the components selected from the group consisting of platelets and leukocytes.

23. The method of claim 19 further comprising priming the separator with anticoagulant and saline mixture.

24. The method of claim 19 further including rinsing the separator, treatment bag, and irradiation chamber with saline and returning the resultant rinse solution to the patient.

25. The method of claim 18 wherein the overall treatment time is less than about 70 minutes.

26. The method of claim 25 wherein the overall treatment time is less than about 45 minutes.

27. A method of performing a photopheresis treatment for diseases on a patient comprising:
drawing whole blood from a source;
adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;
separating the mixture of whole blood and anticoagulant into a plurality of blood components according to density;
mixing a photoactivation chemical with at least one of the blood components to form a mixture of the photoactivation chemical and the at least one blood component;
irradiating the combination of the at least one blood component and photoactivation chemical; and returning the irradiated combination to a patient;
wherein the entire photopheresis treatment is completed in less than about70 minutes.

28. The method of claim 27 wherein the entire photopheresis treatment is completed in less than about 45 minutes.

29. The method of claim 27 wherein the at least one blood component is buffy coat, a leukocyte, or platelets.

30. The method of claim 27 wherein the at least one blood component is buffy coat.

31. The method of claim 30 wherein the step of separating the mixture of whole blood and anticoagulant fluid comprises: providing a separator having an inlet, a first outlet, and a second outlet; pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate; and withdrawing plasma and red blood cells from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and red blood cells being withdrawn at rates so as to build up buffy coat in the separator, the plasma being withdrawn via the first outlet and the red blood cells being withdrawn via the second outlet; and upon a predetermined amount of buffy coat building up in the separator, collecting the buffy coat from the separator.

32. The method of claim 31 wherein the step of collecting the buffy coat from the separator comprises discontinuing the withdrawal of red blood cells from the second outlet, thereby causing the red blood cells to push the buffy coat out of the separator via the first outlet; and discontinuing the collecting of buffy coat when red blood cells are detected in an outlet line fluidly connected to the first outlet.

33. The method of claim 31 wherein the step of withdrawing plasma and red blood cells from the separator comprises: withdrawing only the plasma from the separator via the first outlet until a predetermined amount of red blood cells are detected in the separator; and upon the predetermined amount of red blood cells being detected in the separator, withdrawing red blood cells from the separator at a rate so as to maintain the amount of red blood cells present in the separator at approximately the predetermined amount.

34. The method of claim 31 further comprising irradiating the collected buffy coat within an irradiation chamber until a predetermined amount of energy has been transferred to the collected buffy coat, the predetermined amount of energy being sufficient to induce apoptosis.

35. The method of claim 27 wherein the source is the patient, the photopheresis treatment being performed in a closed-loop system.

36. A method of collecting a desired blood component comprising:
providing a separator having an inlet, a first outlet, and a second outlet;
drawing whole blood from a source;
adding an anticoagulant fluid to the whole blood in a predetermined ratio to form a mixture of whole blood and anticoagulant fluid;
pumping the mixture of whole blood and anticoagulant fluid into the separator via the inlet at a selected inlet rate;
separating the mixture into blood components of different densities;

withdrawing plasma and buffy coat from the separator while continuing to pump the mixture of whole blood and anticoagulant fluid into the separator, the plasma and buffy coat being withdrawn at rates so as to build up red blood cells in the separator, the plasma and buffy coat being withdrawn via the first outlet; and upon a predetermined amount of red blood cells building up in the separator, collecting the red blood cells from the separator via the second outlet.