Patent Publication Number: US-2009218535-A1

Title: Flow controllers for fluid circuits

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/031,839 filed Feb. 27, 2008; U.S. Provisional Patent Application 61/031,851 filed Feb. 27, 2008; and U.S. Provisional Patent Application Ser. No. 61/031/861, filed Feb. 27, 2008, all of which are incorporated herein by reference in their entireties. 
    
    
     BACKGROUND 
     The present disclosure relates to devices for controlling and/or diverting the fluid flow within a fluid circuit, and to systems employing such flow controllers. The flow controllers described herein may find application in any environment or field where the ability to control fluid flow from a source to one or more a destinations is desired or required. The flow controllers and the systems using such flow controllers find particular application in the medical field and, more specifically, in the field of collecting and processing blood collected from a donor. 
     In that regard, a disposable plastic container and tubing set or fluid circuit is typically used for collecting blood from a donor. The disposable blood collection set or circuit includes a venipuncture needle for insertion into the arm of the donor. The needle is attached to one end of a flexible plastic tube which provides a flow path for the blood. The flow path communicates with one or more plastic containers for collecting the withdrawn blood. 
     The blood collection circuit may typically include a sampling sub-unit. The sampling sub-unit allows for collection of a sample of blood, which sample can be used for testing of the blood. Preferably, the sample is obtained prior to the “main” collection of blood. Collecting the sample prior to the main collection reduces the risk that bacteria residing on the donor&#39;s skin where the needle is inserted (i.e., in particular, the small section of detached skin commonly referred to as the “skin plug”) will enter the collection container and contaminate the blood collected for transfusion. Thus, it is preferred that the blood sample, which may include the skin plug, be diverted from the main collection container. 
     Examples of blood collection sets or circuits with such a “pre-donation” sampling sub-units are described in U.S. Pat. Nos. 6,387,086 and 6,520,948 and in U.S. Patent Application Publication Nos. 2005/0215975 and 2005/0148993, all of which are hereby incorporated herein by reference. The fluid processing circuits described therein are similar to the circuit  10  illustrated in  FIG. 1 . Fluid processing circuit  10  includes venipuncture needle  12  and a length of tubing  14 , defining a flow path, one end of which communicates with needle  12  and the other end of which communicates with the inlet port of a Y-junction  16 . The fluid circuit also includes two additional flow paths  18  and  20  which are branched from the outlet ports of the Y-junction  16 . The first branched line  18  communicates with a sample pouch  20  for collecting a smaller volume of blood from which samples may be obtained. Typically, approximately 50 ml of blood is a sufficient amount to provide an adequate sample size and to clear the skin plug from the tubing set. The second branched line  20  communicates with the main collection container  24  that is typically adapted to collect a larger quantity of blood than the sample pouch  20  after the initial sample has been taken. Fluid processing circuit  10  may also include additional satellite containers  26  and  28  for further processing of the collected blood. 
     The blood collection circuit  10  of  FIG. 1  also includes flow control clamps  34 , for controlling the flow of biological fluid (e.g., blood) through the set. The three ports of the Y-junction  16  are always open, so the tubing associated with each must include separate means for regulating flow therethrough. Flow control clamps commonly used are the Roberts-type clamps, which are well known in the art. Clamps of this type are generally described in U.S. Pat. Nos. 3,942,228; 6,089,527; and 6,113,062, all of which are hereby incorporated herein by reference. The clamp described in U.S. Patent Application Publication No. 2005/0215975 may instead be used in operations where it is desirable to irreversibly close flow through a flow path. 
     The clamps  34  are typically placed on the tubing line  14  leading to the Y-junction  16  and on the tubing line  18  leading to the sample pouch  20 , respectively. A clamp may also be placed on the tubing line  20  leading to the main collection container  28 , but flow through that tubing line  20  is frequently regulated by a breakaway (frangible) cannula  36 , as illustrated in  FIG. 1 . By selectively opening and closing the different flow paths (by depressing or releasing the clamps or breaking the frangible cannula), the technician can control the flow of blood from the donor, diverting the blood to the desired output zone. 
     In a typical application, the clamp  34  on the initial length of tubing  12  is closed and venipuncture is performed on the donor. Thereafter, the clamps  34  are opened to allow a small amount of blood to be collected in the sample pouch  20  for later analysis and to clear the skin plug. When the desired amount of blood has been collected in the sample pouch  20 , the clamp  34  between the Y-junction  16  and the sample pouch  20  is closed and the breakaway cannula  36  is broken to allow blood flow to the main collection container  24 . Flow to the sample pouch  20  should be permanently closed, in order to prevent the skin plug from migrating into the main collection container  24  and to prevent anticoagulant from migrating to the sample pouch  20  from the main collection container  24 . 
     Clearly, the above-described process involves several steps and the manipulation of a number of different components, such as clamps and frangible cannulas. Therefore, there exists a need for improved and easy to operate flow controllers and methods that reduce the number of components in the blood collection sets (e.g., clamps and frangible cannulas) and reduce the number of steps that the operator is required to remember and perform, thereby simplifying the process of collecting separate amounts of blood. 
     SUMMARY 
     The present disclosure is directed to a flow controller assembly that includes an inlet member and outlet member cooperatively associated with each other and adapted for relative rotation about a central axis. The flow controller also includes a sealing member carried by one of said inlet or outlet members. The sealing member includes a single flow channel extending therethrough. 
     The present disclosure is also directed to a fluid processing circuit that includes a first flow path adapted for communication with a fluid source and a second flow path. The circuit includes a flow controller assembly between the first and second flow paths. The flow controller includes a first portion and a second portion cooperatively associated with each other and adapted for relative rotation about a central axis. The flow controller assembly also includes a sealing member between the portions and carried by one of the portions. The sealing member has a single flow channel extending therethrough. The flow controller assembly includes an inlet port communicating with the first flow path and an outlet port communicating with the second path. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a plan view of disposable fluid circuit typically used for collecting and processing blood from a donor. 
         FIG. 2  is a plan view of a fluid processing circuit used for collecting and processing blood from a donor including a flow controller assembly as described herein. 
         FIG. 3  is a perspective view of one embodiment of a flow controller assembly described herein. 
         FIG. 4  is an exploded view of the flow controller assembly of  FIG. 3 . 
         FIG. 5  is a cross-sectional view of the flow controller assembly of  FIG. 3  taken along line  5 - 5 . 
         FIG. 6  is a plan view of the flow controller assembly of  FIG. 3 . 
         FIG. 7  is a plan view of the flow controller assembly of  FIG. 6  rotated 90°. 
         FIG. 7(   a ) is an inlet end view of the flow controller assembly of  FIG. 7 . 
         FIG. 7(   b ) is the outlet end view of the flow controller assembly of  FIG. 7 . 
         FIG. 7(   c ) is a cross-sectional view of the flow controller of  FIG. 7(   b ) taken along line  7 ( c )- 7 ( c ). 
         FIG. 7(   d ) is a cross-sectional view of the flow controller of  FIG. 7(   b ) taken along line  7 ( d )- 7 ( d ). 
         FIG. 8  is a perspective view of the sealing member of the flow controller of  FIG. 7 . 
         FIG. 8(   a ) is a plan view of the sealing member of  FIG. 8 . 
         FIG. 8(   b ) is a proximal end view of the sealing member of  FIG. 8 . 
         FIG. 8(   c ) is a side view of the sealing member of  FIG. 8 . 
         FIG. 8(   d ) is a distal end view of the sealing member of  FIG. 8 . 
         FIG. 9  is a plan view of another embodiment the flow control assembly described herein including a single inlet and dual outlets. 
         FIG. 10  is a plan view of the flow control assembly of  FIG. 9  rotated approximately 90°. 
         FIG. 10(   a ) is an inlet end view of the flow control assembly of  FIG. 10 . 
         FIG. 10(   b ) is the outlet end view of the flow control assembly of  FIG. 10 . 
         FIG. 10(   c ) is a cross-sectional view of the flow controller of  FIG. 10(   b ) taken along line  10 ( c )- 10 ( c ). 
         FIG. 10(   d ) is a cross-sectional side view of the flow controller of  FIG. 10(   b ) taken along lines  10 ( d )- 10 ( d ). 
         FIG. 11  is an embodiment of another embodiment of flow controller assembly described herein including a single inlet and single outlet. 
         FIG. 12  is a plan view of the flow controller assembly of  FIG. 11  rotated 90°. 
         FIG. 12(   a ) is an inlet end view of the flow controller of  FIG. 12 . 
         FIG. 12(   b ) is an outlet end view of the flow controller of  FIG. 12 . 
         FIG. 12(   c ) is a cross-sectional side view of the flow controller of  FIG. 12(   b ) taken along line  12 ( c )- 12 ( c ). 
         FIG. 12(   d ) is a cross-sectional side view of the flow controller of  FIG. 12(   b ) taken along line  12 ( d )- 12 ( d ). 
         FIG. 13  is a plan view of another embodiment of the flow controller assembly disclosed herein including a single non-centered inlet and three outlets. 
         FIG. 14  is a plan view of the flow control assembly of  FIG. 13  rotated 90°. 
         FIG. 14(   a ) is an inlet end view of the flow controller of  FIG. 14 . 
         FIG. 14(   b ) is an outlet end of the flow controller of  FIG. 14 . 
         FIG. 14(   c ) is a cross-sectional view of the flow controller  FIG. 14(   b ) taken along line  14 ( c )- 14 ( c ). 
         FIG. 14(   d ) is a cross-sectional view of the flow controller of  FIG. 14(   b ) taken along line  14 ( d )- 14 ( d ). 
         FIG. 15  is a perspective view of the sealing member of flow control assembly of  FIG. 13 . 
         FIG. 15(   a ) is a side view of the sealing member of  FIG. 15 . 
         FIG. 15(   b ) is an inlet end view of the sealing member of  FIG. 15 . 
         FIG. 15(   c ) is a side view of the sealing member of  FIG. 15(   b ). 
         FIG. 15(   d ) is an outlet end view of the sealing member  FIG. 15(   c ). 
         FIG. 16  is a plan view of another embodiment of the flow control assembly described herein. 
         FIG. 17  is a plan view of the flow control assembly of  FIG. 16  rotated 90°. 
         FIG. 17(   a ) is an inlet end view of the flow controller of  FIG. 17 . 
         FIG. 17(   b ) is an outlet end view of the flow controller of  FIG. 17 . 
         FIG. 17(   c ) is a cross-sectional view of the flow controller of  FIG. 178  taken along line  17 ( c )- 17 ( c ). 
         FIG. 17(   d ) is a cross-sectional view of the flow control assembly of  FIG. 17  taken along line  17 ( d )- 17 ( d ). 
         FIG. 18  is another embodiment of the flow controller assembly described herein. 
         FIG. 19  is a plan view of the flow control assembly of  FIG. 18  rotated 90°. 
         FIG. 19(   a ) is an inlet end view of the flow controller of  FIG. 19 . 
         FIG. 19(   b ) is an outlet end view of the flow controller of  FIG. 19 . 
         FIG. 19(   c ) is a cross-sectional view of the flow controller of  FIG. 19  taken along lines  19 ( c )- 19 ( c ). 
         FIG. 19(   d ) is a cross-sectional view of the flow controller of  FIG. 19  taken along  FIG. 19(   d )- 19 ( d ). 
         FIG. 20  is a cross-sectional view of another embodiment of a flow controller described herein with the flow control button in a first position. 
         FIG. 21  is a cross-sectional view of the flow controller of  FIG. 20  with the button depressed to the second flow position. 
         FIG. 22  is another embodiment of the flow controller of  FIG. 20  including a single inlet and single outlet with the flow control button in the open flow position. 
         FIG. 23  is the flow controller of  FIG. 22  with the button in the depressed to the closed flow position. 
         FIG. 23A  is a perspective view of the button of  FIGS. 21-23 . 
         FIG. 24  is another embodiment of a flow controller described herein with the controller in a closed flow position. 
         FIG. 25  is a cross-sectional view of the flow controller of  FIG. 24  as the controller is moved from the closed flow position to the open flow position. 
         FIG. 26  is a cross-sectional side view of the flow controller of  FIGS. 24 and 25  in an open flow position. 
         FIG. 27  is a view of the mold for making the flow controller of  FIGS. 24-25 . 
         FIG. 28  is a cross-sectional view of the mold with core pins being removed from the mold. 
         FIG. 29  shows an alternative method of molding the flow controller of  FIGS. 24-26 . 
         FIG. 30  is a view of the molding operation of  FIG. 29  with the core pins being removed from the mold. 
         FIG. 31  is a cross-sectional view of the flow controller of  FIGS. 24-26  after molding. 
         FIG. 32  is a cross-section view of the flow controller of  FIG. 31  with a cap. 
         FIG. 33  is a cross-sectional view of the flow controller of  FIG. 32  with an additional membrane placed thereon. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The flow controller assembly and flow controllers generally described herein provide a way to divert flow from one destination to another destination and/or provide an easy-to-use on/off switch for selectively opening and restricting flow through a flow path of a fluid circuit. Typically, use of the flow controller assemblies and flow controllers described herein will result in elimination of multiple clamps and frangible devices. The flow controllers described herein may be used in any environment where it is desirable to restrict or otherwise divert flow within a fluid circuit. More specifically, the flow controllers and flow controller assemblies of the present disclosure find particular application and use in the medical field and even more particularly in the field of blood processing and collection where control and diversion of fluid flow is often desired. 
     Thus, as shown in  FIG. 2 , a fluid processing circuit  10  includes a first flow path defined by tubing  14  that communicates with a fluid source, such as a donor, through venipuncture needle  12 . Fluid processing circuit  10  includes a flow controller  40  that communicates with the first flow path defined by tubing  14 . Specifically, flow path  14  communicates with an inlet port of flow controller  40 . As shown in  FIG. 2  and in more detail in later figures, flow controller assembly includes one or more outlets that communicate with second (and other) flow paths. These flow paths, defined by tubings  18  and  22  communicate with containers ( 20 ,  24 ) of the fluid processing system as previously described. Flow controller  40  allows the user to direct and/or divert flow to a second or other flow path as necessary. 
     Turning to  FIG. 2 , a fluid processing system used in the processing of blood or other biological fluids with a flow controller of the type described herein is shown. In many respects, fluid circuit  10  of  FIG. 2  is identical to the fluid circuit shown in  FIG. 1 . Accordingly, identically numbered elements in  FIG. 2  refer to the same element described with reference to  FIG. 1 . It should be noted, however, that in lieu of branch member  16 , clamp  34  and frangible device  36 , a flow controller or flow controller assembly  40  as described below may be employed. Of course, it will be understood by those of skill in the art that clamps  34  and frangibles  36  may still be used to provide additional means for fluid control. 
     Flow controller assembly  40  shown in  FIG. 3  is one embodiment of a flow control device or flow controller that is the subject of the present disclosure. Flow controller assembly  40  is shown in greater detail in  FIGS. 3-5 . As shown in these figures, flow controller assembly  40  is made of several interconnected and moveable parts, Flow controller assembly  40  includes a first portion such as an inlet member  42 , a second portion such as an outlet member  44  and a sealing member  48  disposed between inlet member  42  and outlet member  44 . Inlet member  42  includes an inlet port  46  which, with reference to  FIG. 2  and as described above, is in flow communication with fluid flow path  14 . Turning briefly to  FIG. 5 , inlet member  42  further defines an inlet channel  58  that extends from port  56  to sealing member  48 . Thus, in the case of the blood processing system of  FIG. 2 , an uninterrupted flow path may be provided from the donor through needle  12  to flow controller assembly  40 . 
     Outlet member  44  includes one or more outlet ports  60 ,  62  and  64  extending from the distal end of outlet member  44 . The number of outlets will depend on the number of destinations for the blood or other fluid to be collected. Thus, where flow from the inlet is to be collected or directed to three separate destinations e.g., containers), flow controller assembly will have three outlets as shown in  FIGS. 3-7  and  13 - 14 . Where flow is to be directed to two separate destinations (as, for example, in the fluid circuit of  FIG. 2 ), flow controller assembly may have only two outlets as shown in  FIGS. 9-10  and  16 - 17 . Where flow from the inlet is to be directed to a single destination and flow controller assembly  40  acts as an ON/OFF switch, one outlet port may be provided. With reference to  FIG. 2 , outlet ports  60 ,  62  and  64  communicate with collection line  22 , sample line  18  and other lines as necessary or desired. In the embodiment of  FIGS. 3-5  inlet port is coaxial with central axis  46  of flow control assembly  40 . Outlet ports  60 ,  62  and/or  64  are spaced off center and around the central axis  46  and, as shown specifically in the embodiment of  FIG. 4 , are separated by approximately 120°. 
     Flow controller assembly  40  may be made of rigid plastic material that is biocompatible and sterilizable by known methods of sterilization for medical products. This may include steam sterilization (or autoclaving) or radiation sterilization. Examples of suitable materials include, but are not limited to polycarbonate polyethylene and polypropylene. As shown in  FIGS. 3-5 , outer surfaces of flow control assembly  40  and, specifically, inlet members  42  and outlet member  44  may be knurled or otherwise textured to provide easier finger gripping by the user. 
     Located between inlet member  42  and outlet member  44  is sealing member  48 . Sealing member  48  is preferably made of a resilient and biocompatible material such as silicone or rubber. As shown in  FIGS. 3-5  and, specifically,  FIG. 8 , sealing member  48  includes a flow channel  49  extending therethrough. As previously described, flow channel  49  of sealing member  48  is in flow communication with inlet channel  58  and inlet port  56 . As further seen in  FIG. 8 , in one embodiment, sealing member  48  is relatively thick and in the shape of a T-shaped disk. That is, sealing member  48  has a generally cylindrical distal portion  72  and a proximal portion  74 . When viewed from one perspective, seen best in  FIG. 8A , sealing member  48  defines a T-shaped profile. Proximal end portion  72  of sealing member  48  may be shaped and sized to be press fit and/or keyed into a corresponding notch  52  in the distal end of inlet member  42  as best seen in  FIG. 3 . Of course, proximal portion  74  of sealing member may be square, or octagonal or provided in a different shape with notch  52  being correspondingly shaped to receive proximal portion  74 . Thus, sealing member  48  is preferably carried by inlet member  42 . Consequently, because sealing member is mechanically linked to and driven by inlet member, rotation of inlet member  42  rotates sealing member  48  and flow channel  49  accordingly. Variations of suitable drive linkages include a square drive, a slot drive and a star-shaped drive. To aid in rotation of sealing  48  within outlet member  44 , the distal surface of sealing member  48  may be lubricated. 
     Inlet member  42  and outlet  44  are cooperatively associated with one another in a way that allows for relative rotation of members  42  and  44 . In one embodiment, outlet member  44  may include a circumferential groove  52  on the inner surface of outlet member  44 . Inlet member  42  may include a continuous or semi-continuous circumferential rib  54  as seen in  FIG. 4  on the outer surface of inlet member  42 . Alternatively, these elements may be reversed with inlet member  42  including a groove on its outer surface and outlet member  44  including a rib on its inner surface. In any event, inlet members  42  and outlet member  44  may be cooperatively associated with one another by snap-fitting the rib  54  into groove  52  and allowing for relative rotation of the members. Thus, the inlet member  42  and outlet member  44  snap together compressing sealing member  48 . 
     As shown in  FIGS. 3-5  and  6 - 19 , outlet member  44  includes an axially extending finger  76 . Once flow control assembly  40  is assembled, finger  76  extends beyond the proximal end of outlet member  44 . Inlet member  42  includes one or more sets of stops  78  on its outer surface near its distal end allowing for cooperative engagement with finger  76 . As shown in  FIG. 3 , a pair of stops  78  provides a space or gap in which finger  78  is captured and held. This arrangement restricts rotation of relative rotation of inlet member  42  and outlet member  44  as necessary. As seen in  FIGS. 5 and 7(   a ),  10 ( a ),  12 ( a ), stops  78  may be raised surfaces or protuberances extending from the outer surface of inlet member  44 . The stops may also be ratchets or other types of catches sufficient to restrict or prevent rotation or movement of finger  76 .  FIG. 7(   a ) shows three types of retaining members including a pair of stops ( 78 ( a ), a pair of detents  78 ( b ) or a combination of a ratchet and stop  78 ( c ). Any other pair or combination of stops, catches, protuberances, detents or other retaining means for limiting, restricting or preventing movement of finger  76  and, thus, outlet member  44  may be employed. The stops or other retaining members described above may be identified by a number or other identifier that corresponds to the outlet that is aligned with or in flow communication with inlet  56 . The identifier may be printed or otherwise indicated on inlet member  42  in close proximity to the stops  78 . In addition, identifier may be located on outlet member  42  such that when finger  76  is retained by stops  78  or resides in the space between the stops, finger  76  and, more specifically, line marker  77  on finger  76 , is aligned with the outlet port identifier. Finger  76  and cooperating stops  78  may be shaped or otherwise dimensioned to either temporarily restrain finger  78 , but otherwise allow finger  76  to “ride over” stops or ratchets when rotation and alignment of the ports is desired. In this regard, the surfaces of stops can be curved or rounded as necessary. Alternatively, when no further rotation is desired or the ability to rotate inlet member and/or outlet member back to another position, one stop or one set or pair of stops  78  and/or finger may be dimensioned to prevent such rotation by not allowing finger  76  to ride over the retainer, and create, in effect, a substantially irreversible locking feature. 
     As shown in  FIGS. 3-12 , inlet port  56  of inlet member  42  is centered along central axis  46 . Flow controller assembly  40  and, more specifically, outlet member  44 , may include one or more outlet ports off of and around the central axis  46 . In order to establish flow communication between centered inlet port  56  and off-center outlet ports  60 ,  64  and  68  and, more specifically, the outlet port channels  62 ,  66  and  70  defined thereby, seal member flow channel  49  will preferably have an oval-like cross-section. Seal member flow channel  49  with an oval-like cross-section is best seen in  FIG. 8  and, specifically, in  FIGS. 8(   a )- 8 ( d ). As shown  FIGS. 7(   d ),  10 ( d ) and  12 ( d ), an elongated or oval-like aperture as described above establishes flow communication between centered inlet port  56  and one of outlet ports  60 ,  64  or  68 . 
     In an alternative embodiment, inlet port  62  may be off-center or otherwise spaced from the central axis  46 , with outlets  60 ,  64  and  68  positioned as described above, i.e., also off-center and placed around central axis  46  of flow controller assembly  40 . In this embodiment, sealing member  48  may have a substantially circular cross-section as shown in  FIG. 15  generally and  FIGS. 15(   a )- 15 ( d ) specifically. 
     In each of the embodiments rotation of inlet member  42  and outlet member  44  establishes flow communication from a source to a destination. Where flow controller assembly  40  includes a single inlet and a single outlet, flow control assembly acts as a simple on/off switch which either allows or restricts flow. Where flow control assembly includes multiple outlets, flow control assembly  40  provides the user with the ability to divert flow from one destination (such as container  20 ) to another destination (such as container  24 ) or another two destinations. The number of outlets is not limited to three and additional outlets may be included in flow controller assembly  40 . The number of outlets will, in part, be determined by the size of flow control assembly  40 . Flow control is achieved by twisting one or both of inlet member  42  and outlet member  44  so as to align inlet  56  with the desired outlet  60 ,  64  and/or  68 . A fluid path from the source to the destination is established when the inlet flow channel  58  is aligned with sealing member flow channel  49  and the outlet port flow channel  62  or  66  or  70 . 
     An alternative embodiment of a flow controller is shown in  FIGS. 20-23  and is described below. Flow controller  80  of  FIGS. 20-23  may likewise serve as a fluid diversion device (as shown in  FIGS. 20-21 ) or ON/OFF switch as shown in  FIGS. 22-23 . In either embodiment, flow controller  80  includes a housing  82  with one inlet  84  and one or multiple outlet ports  86  and  88 , and a movable button  90  adapted for movement within the flow channel  83 . 
     As shown in  FIG. 23(   a ), the button is preferably a cylinder with multiple axial ribs  98  or seals. The button is shaped to be wider at its ends with a narrower diameter in the center, thereby providing a fluid path between inlet  84  and outlet  86  and  88  around this narrow cylindrical section. Bufton  90  can be made as a solid piece, preferably made of biocompatible plastic with glands to accept rubber or silicone O-rings of a selected size. Alternatively, button  90  can be molded as a solid piece with an overmold of a soft material to form the multiple ribs  98  or seals. Button  90  fits into the housing thereby forming an axial fluid seal. A through hole or vent  100  at the center of button  90  serves as a vent for air to escape when button  90  is depressed into housing cavity  83 . Housing  82  has open ports  84 ,  86  and  88  extending from opposing side walls as shown in the Figures. 
     As shown in  FIG. 20 , in an initial state, fluid entering inlet  84  can only pass to outlet port  86 . Fluid cannot pass to outlet port  88 . Seal or rib  98 ( c ) prevents fluid flow to port  88 . Seal formed by ribs  98 ( d ) prevents any fluid within outlet port  88  from entering into chamber at distal end of device. When button  90  is depressed, as shown in  FIG. 21 , the fluid path direction changes. Fluid can only pass from inlet port  84  to outlet port  88 . Fluid cannot pass to outlet port  86 , as seal  98 ( b ) prevents fluid to pass to port  86 . Seal  98 ( a ) prevents any fluid within outlet port  86  from re-entering or dripping back into proximal end of flow controller  80 . As shown in  FIGS. 20-21 , an optional bellows  106  may be provided as a dust shield and as a sterile barrier. 
     As shown in  FIGS. 22-23  depict flow controller  80  may be provided as an ON/OFF switch with 2 ports, an inlet  84  and an outlet  86 . Movement of button  90  closes a normally open flow path or opens a normally closed flow path. For example, in  FIG. 22 , flow controller  80  is configured as a NO (normally open) fluid switch with only two ports. In the initial position, fluid path is open from (bottom) inlet port  84  to (top) outlet port  86 . When button  90  is pressed, the flow path is closed and further flow to outlet  86  is prevented by fluid seals  98 ( a ) and  98  ( b ). 
     In  FIG. 23 , flow controller  80  is configured as a NC (normally closed) fluid switch illustrated with only two ports. In the initial position, fluid path is closed. Fluid seals or ribs  98 ( c ) prevent fluid from entering outlet  86 . When button  90  is depressed, the flow is open from (bottom) inlet port  84  to (top) outlet port  86 . 
     In another embodiment, flow controller may be provided as an ON/OFF switch where a simple press of the housing wall will open (or close) fluid flow, although more typically, it may be used one time only to open a fluid path. Once open, it is preferably difficult and impractical to return to a closed state. 
     An example of such a flow controller is shown in  FIGS. 24-26 . Flow controller  120  includes a flexible housing  122  with an inlet port  124  and outlet port  126 , Ports  124  and  126  are in flow communication with flow paths  18  and  22  of the fluid circuit  10 . A solid ball  134  is located within the center of housing  122 . In its initial state, the ball prevents fluid passage. Ball  134  is larger than the port opening, thus creating a seal at high fluid pressure. Above ball  134  is an empty pocket  130  or cavity to accept the ball size. A simple press on the outside of housing  122  will displace and transfer ball  134  into empty pocket  130  thus allowing for a fully open flow path  128  across inlet  124  and outlet  126  port. Housing  122  may include a depression or concave surface resulting in a thinner housing wall at depression  123  where the user may apply pressure to dislodge ball  134  from the flow path. This fluid switch described above is preferably intended for one time use and once flow path  128  is opened it is preferably not intended to be closed again. It is intended to be difficult and impractical to return the ball to its original position. 
     The ball-actuated flow controller described herein has several advantages over the previous breakable cannula frangible and stopcock devices. For example, flow controller may be activated with one hand operation. When actuated, the fluid path is opened without any restriction. Furthermore, the device is easy to use. Finally, flow controller  120  may be manufactured by a simple molding process. 
     For example, the ball actuated flow controller  120  may be molded as one piece from a biocompatible and sterilizable material such as polyvinyl chloride, certain medical grade rubbers or other plastics. Ball may be made of a biocompatible plastic, steel or other hard material suitable for use in medical procedures, In one embodiment, as shown in  FIG. 29-30 , ball  134  is captured and molded within the flexible housing by means of an injection molding process. Ball  134  is preferably made of a material different from the material of housing  122  such that ball  134  will not crosslink with the flexible housing  122  material. Thus, ball  134 , when necessary, will be moveable from its original position into the adjacent empty pocket  130 . Ports  124  and  126  and flow path  128  are formed with side action core pins  138 ,  140 ,  142  known in the molding industry. Core pins  138 ,  140 ,  142  hold ball  134  in position as the plastic material fills the mold  150 . As shown in  FIGS. 28 and 30 , the ends of core pins  138 ,  140  and  142  which contact the surface of ball  134  are shaped to match the curvature of the ball surface or milled with V-bit shape. Core pin ends may also be hollow tubes and ground to match the curve surface of the ball  134 . After the material is injected and cools, the core pins retract and form the ports and the empty cavity. 
     The ball actuated flow controller  120  may also be molded without the ball such that the ball is assembled at a later time as shown in  FIGS. 27-28 . The spherical cavity  143  created would be smaller in size than the size of the ball. This results in providing a compression seal against the ball once it is insert assembled. 
       FIG. 31  shows cross section of the device when removed from the mold. In this regard, ball  134  may be introduced into flow controller  120  through the open top of flow controller  120 . Once ball  134  has been introduced into spherical cavity  143 , a plug or cap  144  may be overmolded or otherwise applied to over the open top to seal flow controller  120 . A membrane sheeting  146  may be applied to the open top or applied over plug or cap  144 . 
     The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is defined in the claims below.