Abstract:
A drop controlling and counting valve on key system, and a method for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, under control of a hand-held computer serving as an authentication unit, the hand-held computer containing characteristics of the medication fluid and details of the patient, for calculating a correlation value between the details and the characteristics and having a control unit serving as a key for opening and controlling passage of the medication dripping through a smart valve.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to means and a method designated to prevent medical errors when injecting IV fluids and medications into humans and animals, and, in particular to ensure authentication of medications infused in IV bags. 
       BACKGROUND OF THE INVENTION 
       [0002]    An apparatus, system and method for administration of a substance is described in the International Application PCT/IL/2005/001118 of Sharvit et al., International Publication Number WO 2006/046242, which is incorporated by reference for all purposes as if fully set forth herein. 
         [0003]    WO 2006/046242 discloses an infusion control valve adapted to be actuated by a valve actuator, an infusion valve actuator adapted to actuate an infusion control valve upon being triggered by an authentication unit and a method for the administration of a substance. 
         [0004]    The method according to WO 2006/046242 also uses a hand-held (HHD) computer and a smart (electronic) key. 
         [0005]    Means and a method of prevention of error and ensuring authentication of medications infused in IV bags and syringes, and other authentication, such as the verification of movement of fluids in all directions from bags to vials, bags to syringes, and syringes to vials, is described in the U.S. provisional patent application No. 61/006,578 of Sharvit et al., which is incorporated by reference for all purposes as if fully set forth herein. 
         [0006]    U.S. 61/006,578 discloses a drug port valve which has two working modes, a closed mode which completely prevents the passage of fluid, and an open mode which requires authentication and which enables the passage of fluid. 
         [0007]    There is a need for a means and a method designated to prevent medical errors when injecting IV fluids and medications into humans and animals, and, in particular to ensure authentication of medications infused in IV bags, which enable controlling and monitoring the output of IV fluid passing through such a valve. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention relates to system, means and a method of use, designated to prevent medical errors when injecting IV fluids and medications into humans and animals, and, in particular to ensure authentication of medications infused in IV bags, which enable control and monitoring the output of IV fluid. 
         [0009]    The flow through the means is at a dripping rate, as is common in fluid IV&#39;s, and the system, according to the present invention, enables closed circuit monitoring of the output, namely the dripping rate, while the mass of the drops is known and enables selection of desired output parameters, such as the number of drops per time unit and the beginning and end times of the flow, all under the condition of authentication. 
         [0010]    These system, means and method are according to the present invention, some of whose inventors are also inventors of WO 2006/046242, and U.S. 61/006,578 and are designated to add further performance to the family of system, means, and method of the prior invention. 
         [0011]    According to some embodiments of the present invention there is provided a drop controlling and counting valve on key system for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, under control of an authentication unit, the authentication unit containing characteristics of the medication fluid and details of the patient, for calculating a correlation value between the details and the characteristics, the drop controlling and counting valve on key system including: (A) a smart valve including: (i) an immovable assembly including: (a) a smart valve to control unit connector; and (B) a control unit including: (i) a control unit to smart valve connector, wherein the smart valve to control unit connector and the control unit to smart valve connector are compatible; and (ii) a control unit wireless communication subsystem. 
         [0012]    According to still further features in the described embodiments the drop control and controlling valve on key system further includes: (C) a hand-held computer including: (i) a hand-held computer wireless communication subsystem, wherein the control unit wireless communication subsystem and the hand-held computer wireless communication subsystem are compatible. 
         [0013]    According to still further features in the described embodiments the immovable assembly further includes: (b) a lock pin, having no movement capability relative to the immovable assembly; (c) a dripping chamber positioned at a lower section of the immovable assembly at times of a normal operation; (d) a lower connector attached to the dripping chamber; (e) a transmitter light guide disposed between the dripping chamber and the smart valve to control unit connector; and (f) a receiver light guide disposed between the dripping chamber and the smart valve to control unit connector. 
         [0014]    According to still further features in the described embodiments the smart valve further includes: (ii) a moveable assembly, wherein the moveable assembly has a limited movement capability within the immovable assembly, and wherein the immovable assembly includes: (a) a spike having a shape and dimensions suitable for insertion in an IV bag first port. 
         [0015]    According to still further features in the described embodiments the smart valve further includes: (iii) an internal tubule disposed between the spike and the lower connector. 
         [0016]    According to still further features in the described embodiments the moveable assembly further includes (b) a lock having angular movement capability, wherein the lock does not block flow of fluid within the internal tubule during times of storage; (c) a lock hook for locking the lock in a position pressing on the internal tubule; and (d) a drop controller means for controlling the rate of fluid dripping through the internal tubule. 
         [0017]    According to still further features in the described embodiments the control unit further includes: (iii) an optical transmitter, wherein when the control unit is engaged to the smart valve, the optical transmitter is positioned opposite the transmitter light guide; (iv) an optical receiver, wherein when the control unit is engaged to the smart valve, the optical transmitter is positioned opposite the receiver light guide; and a control unit locker having angular movement capability, and wherein when the control unit is connected to the smart valve, the control unit locker can prevent disengagement of the control unit from the smart valve. 
         [0018]    According to still further features in the described embodiments the control unit further includes: (vi) a locking shaft having rotational movement capability; (vii) a combining ligule disposed as part of the locking shaft, wherein the combining ligule has a shape and dimensions suitable for engagement with the drop controller means; and (viii) a cam disposed as part of the locking shaft, wherein the cam has a shape and dimensions suitable for moving the control unit lock in order to enable disengagement of the control unit from the smart valve. 
         [0019]    According to still further features in the described embodiments the control unit further includes: (ix) a step motor, the step motor having a step motor shaft; (x) a first cogwheel disposed at the step motor shaft; and (xi) a second cogwheel disposed at the locking shaft, wherein the first cogwheel and the second cogwheel constitute a control transmission. 
         [0020]    According to still further features in the described embodiments the control unit further includes: (xii) a microcontroller capable of operating the step motor; and (xiii) a power source, for supplying power to the step motor and to the micro-computer. 
         [0021]    According to still further features in the described embodiments the control unit further includes: (iii) an optical transmitter, wherein when the control unit is engaged to the smart valve, the optical transmitter is positioned opposite the transmitter light guide; (iv) an optical receiver, wherein when the control unit is engaged to the smart valve, the optical transmitter is positioned opposite the receiver light guide; a control unit lock having angular movement capability, and wherein when the control unit is connected to the smart valve, the control unit lock can prevent disengagement of the control unit from the smart valve; (vi) a locking shaft having rotational movement capability; (vii) a combining ligule disposed as part of the locking shaft, wherein the combining ligule has a shape and dimensions suitable for engagement with the drop controller means; (viii) a cam disposed as part of the locking shaft, wherein the cam has a shape and dimensions suitable for moving the control unit lock in order to enable disengagement of the control unit from the smart valve; (ix) a step motor, the step motor having a step motor shaft; (x) a first cogwheel disposed at the step motor shaft; (xi) a second cogwheel disposed at the locking shaft, wherein the first cogwheel and the second cogwheel constitute a control transmission; (xii) a microcontroller capable of operating the step motor; and (xiii) a power source, for supplying power to the step motor and to the micro-computer. 
         [0022]    According to some embodiments of the present invention there is provided a method for controlling the rate of flow of medications, in liquid state drops, infused in IV bags, the method including the stages of: (A) providing a drop controlling and counting valve on key system, the drop controlling and counting valve on key system including: (i) a first smart valve having a spike; (ii) a control unit; and (iii) a hand-held computer; (B) inserting the spike in an IV bag port, wherein the insertion causes a state of prevention of fluid flow from the IV bag through the first smart valve; (C) connecting the control unit to the first smart valve; (D) scanning a vial barcode sticker and a wristband patient barcode by the hand-held computer, and assessing an authentication; (E) opening a pass which enables flow of fluid through the first smart valve; and (F) measuring the flow rate of fluid, by counting fluid drops passing through the first smart valve, over a given period of time, wherein the average mass of a drop is known. 
         [0023]    According to still further features in the described embodiments the method for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, infused in IV bags further including the stages of: (G) calculating an amount of fluid mass passing through the first smart valve; and (H) preventing flow of fluid through the first smart valve, after finding that a fluid mass of a predetermined amount passed through the first smart valve. 
         [0024]    According to still further features in the described embodiments the method for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, infused in IV bags further including the stages of: (I) disconnecting the control unit from the first smart valve; and (J) extracting the spike from the IV bag port. 
         [0025]    According to still further features in the described embodiments the method for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, infused in IV bags further including the stages of: (K) destroying the first smart valve. 
         [0026]    According to still further features in the described embodiments the method for ensuring authentication and for controlling the rate of flow of medications, in liquid state drops, infused in IV bags further including the stages of: (L) inserting a spike of a second smart valve in an IV bag port, wherein the insertion causes a state of prevention of fluid flow from the IV bag through the second smart valve; and (M) connecting the control unit to the second smart valve. 
         [0027]    Additional objects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]    The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: 
           [0029]      FIG. 1  is a schematic perspective view illustration of an exemplary embodiment of the three main assemblies of a drop controlling and counting valve on key system, according to the present invention. 
           [0030]      FIG. 2  is a schematic perspective view illustration of an exemplary embodiment of an open control unit, without part of the external casing and additional parts, according to the present invention. 
           [0031]      FIG. 3  is a schematic perspective view illustration of an exemplary embodiment of an open smart valve, according to the present invention. 
           [0032]      FIG. 4  is a schematic front view illustration of an exemplary embodiment of the smart valve, according to the present invention, upon which the section plane a-a is marked. 
           [0033]      FIG. 5  is a cross sectional view a-a schematic illustration of an exemplary, illustrative embodiment of the smart valve, prior to activation according to the present invention. 
           [0034]      FIG. 6  is a schematic side view illustration of an exemplary embodiment of the control unit, according to the present invention. 
           [0035]      FIG. 7  is a schematic perspective view illustration of an exemplary embodiment of a smart valve, according to the present invention, connected to infusion tubule about to be connected to IV bag, according to the present invention. 
           [0036]      FIG. 8  is a schematic side view illustration of an exemplary embodiment of a smart valve, showing its components in a state in which flow is impossible, according to the present invention. 
           [0037]      FIG. 9  is a schematic side view illustration of an exemplary embodiment of a smart valve, showing the state of its components after locking, according to the present invention. 
           [0038]      FIG. 10  is a schematic side view illustration of an exemplary embodiment of a smart valve, which is connected to IV bag prior to connection to a control unit, according to the present invention. 
           [0039]      FIG. 11  is a schematic side view illustration of an exemplary embodiment of a smart valve, which is connected to a control unit, according to the present invention. 
           [0040]      FIG. 12  is a schematic side view illustration of an exemplary embodiment of a smart valve, which is connected to a control unit, according to the present invention. 
           [0041]      FIG. 13  is a schematic perspective view illustration of an exemplary embodiment of a smart valve, integrated with a control unit and connected between an IV bag and an infusion tubule, according to the present invention. 
           [0042]      FIG. 14  is a schematic perspective view illustration of an exemplary embodiment of a smart valve, integrated with a control unit and connected between an IV bag and an infusion tubule, according to the present invention. 
           [0043]      FIG. 15  is a schematic perspective view illustration of an exemplary embodiment of a smart valve, integrated with a control unit and connected between an IV bag and an infusion tubule, according to the present invention. 
           [0044]      FIG. 16  is a schematic side view illustration of an exemplary embodiment of a smart valve, which is connected to a control unit, according to the present invention. 
           [0045]      FIG. 17  is a schematic perspective view illustration of an exemplary embodiment of a smart valve, integrated with a control unit and connected between an IV bag and an infusion tubule, according to the present invention, during adjustment of the control unit. 
           [0046]      FIG. 18  is a schematic side view illustration of an exemplary embodiment of a smart valve, connected to a control unit, according to the present invention. 
           [0047]      FIG. 19  is a schematic side view illustration of an exemplary embodiment of a smart valve, connected to a control unit, according to the present invention. 
           [0048]      FIG. 20  is a schematic side view illustration of an exemplary embodiment of a smart valve, connected between an IV bag and an infusion tubule, according to the present invention, in the stage following disconnection from the control unit. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0049]    The present invention is of drop controlling and counting valve on key system, means and a method of use, designated to prevent medical errors when injecting IV fluids and medications into humans and animals, and, in particular to ensure authentication of medications infused in IV bags, which enable control and monitoring the output of IV fluid. 
         [0050]    The flow, which is in the form of dripping, is through a valve and is controlled by a closed loop controlling sub-system, which can also provide a secure constant rate (according the physician protocol setup), namely, other than mass control it can also control a constant rate. An additional feature of the controlling sub-system is the ability for real-time reporting of every situation to the HHD by means of wireless communication, so that the HHD is updated from all units constantly during the procedure. The control can also include control of the time of beginning and end of dripping. 
         [0051]    Even though in the embodiments described in the present patent application, the drop controlling and counting valve on key system includes one smart valve, one control unit, and one hand-held computer, there may be other embodiments in which one hand-held computer has wireless communication with more than one control unit. 
         [0052]    The principles and operation of a drop controlling and counting valve on key system  1000  according to the present invention may be better understood with reference to the drawings and the accompanying description. 
         [0053]    Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. 
         [0054]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, dimensions, methods, and examples provided herein are illustrative only and are not intended to be limiting. 
         [0055]    The following list is a legend of the numbering of the application illustrations:
         10  infusion bag barcode sticker     17  IV bag     18  IV bag first port     19  IV bag second port     20  infusion tubule         21  patient barcode
         30  fluid drops     40  IR radiation     41  wireless communication     100  smart valve     101  patient barcode     102  vial barcode sticker     103  dripping chamber     104  smart valve to infusion tubule connector     105  spike     106  smart valve to control unit connector     107  moveable assembly     108  immovable assembly     109  drop controller means     110  transmitter light guide     111  receiver light guide     112  internal tubule     113  lower connector     114  lock hook     115  lock     116  lock pin     117  pressure zone     118  drop controller means plane     119  locking wall     120  transmitted light ray     121  reflected light ray     122  integral screw     200  control unit     201  external casing     202  display     203  keyboard     204  control unit to smart valve connector     205  switch     206  step motor     207  control transmission     208  microcontroller     209  power source     210  optical transmitter     211  optical receiver     212  control unit lock     213  first cogwheel     214  second cogwheel     215  step motor shaft     216  locking shaft     217  spring     218  cam     219  combining ligule     220  control unit wireless communication subsystem     300  hand-held computer     301  LCD screen     302  keypad     303  IR radiation     304  hand-held computer wireless communication subsystem     1000  drop controlling and counting valve on key system   
       
 
         [0115]    Referring now to the drawings,  FIG. 1  is a schematic perspective view illustration of an exemplary embodiment of the three main assemblies of a drop controlling and counting valve on key system  1000 , according to the present invention. The three main assemblies are: a smart valve  100  designated for one-time use, a control unit  200  designated for repeated use, and a hand-held (HHD) computer  300  which is also for repeated use. 
         [0116]    The control unit  200  is suitable for connection to the smart valve  100  and for its activation. The hand-held (HHD) computer  300  enables the activation of the control unit  200  through wireless communication, following the connection and calibration of the control unit  200  and receiving a suitable authentication result from examination of the vial barcode sticker and the wristband patient barcode ( 21 ). 
         [0117]    The smart valve  100  has spike  105  assembled to its upper part, and dripping chamber  103  assembled to its lower part. Dripping chamber  103  is a transparent cylinder which serves as a container for formation of the drops, and its lower end has a smart valve to infusion tubule connector  104 . 
         [0118]    The smart valve  100  also includes a smart valve to infusion tubule connector  104 . 
         [0119]    The control unit  200  also includes external casing  201  which is composed of a suitable material, such as plastic for example, and is integrated with a display  202  for displaying work data, as well as a keyboard  203  for entering data and a switch  205 , which is a slider with two modes, connection and disconnection of the control unit  200  to and from the smart valve  100  by means of control unit to smart valve connector  204 . 
         [0120]      FIG. 2  is a schematic perspective view illustration of an exemplary embodiment of an open control unit  200 , without part of the external casing  201  and additional parts, according to the present invention. 
         [0121]    A motor, which can also be an electric step motor  206 , fed from a power source  209 , which can also be a chargeable electric battery, drives control transmission  207 , which includes a first cogwheel  213  and a second cogwheel  214 , and which controls (monitors) the dripping rate of the fluid drops flowing through the smart valve ( 100 ). 
         [0122]    The control unit  200  also includes an optical transmitter  210 , optical receiver  211 , and microcontroller  208 . 
         [0123]      FIG. 3  is a schematic perspective view illustration of an exemplary embodiment of an open smart valve  100 , according to the present invention. 
         [0124]    The smart valve  100  includes two assemblies, an immovable assembly  108 , and a moveable assembly  107 , which moves when activated within the immovable assembly  108 . 
         [0125]    The terms moveable and immovable are used in reference to relative movement of these assemblies with regard to each other, and are in no way limiting their movement with regard to the external environment. 
         [0126]      FIG. 4  is a schematic front view illustration of an exemplary embodiment of the smart valve  100 , according to the present invention, upon which the section plane a-a is marked. The smart valve to control unit connector  106  also includes a drop controller  109 , and two light guides, the transmitter light guide  110 , and the receiver light guide  111 . 
         [0127]      FIG. 5  is a cross sectional view a-a schematic illustration of an exemplary, illustrative embodiment of the smart valve  100 , prior to activation according to the present invention. 
         [0128]    An internal tubule  112  goes through the moveable assembly  107  and is connected to lower connector  113 . Drops can pass through the internal tubule  112  when there is flow of fluid into the dripping chamber  103 . In this state, the lock hook  114  is in open mode when the lock  115  is in its lower position: likewise the lock pin  116 , activates the lock by moving the movable assembly  107 , movable assembly  107  is in the upper position. 
         [0129]    The illustration shows the two light guides, the transmitter light guide  110 , and the receiver light guide  111 , serving for conduction of the light from the optical transmitter  210 , and to the optical receiver  211  through the dripping chamber  103 . In this state, the drop controller means  109  is in a fully closed mode. 
         [0130]    There is still no flow through the internal tubule  112  because there has been no connection to any container of fluid. 
         [0131]      FIG. 6  is a schematic side view illustration of an exemplary embodiment of the control unit  200 , according to the present invention. 
         [0132]    The control unit  200  is activated by microcontroller  208  which is electrically connected to step motor  206 , which activates the control transmission  207 . 
         [0133]    Step motor  206  has a step motor shaft  215 , upon which a first cogwheel  213  is assembled and engaged with a second cogwheel  214 , which is assembled to the locking shaft  216 . 
         [0134]    The locking shaft  216  is regularly engaged by spring  217 . 
         [0135]    The locking shaft  216  also includes a cam  218  serving to open the control unit lock  212 . At the end of the locking shaft  216  is combining ligule  219 , which is designated for controlling the dripping rate by opening and closing the drop controller means ( 109 ) which is disposed within smart valve ( 100 ). 
         [0136]    The optical transmitter  210  also includes a light source such as LED, and the optical receiver  211  also includes a light-sensitive sensor. 
         [0137]      FIG. 7  is a schematic perspective view illustration of an exemplary embodiment of a smart valve  100 , according to the present invention, connected to infusion tubule  20  about to be connected to IV bag  17 , according to the present invention. The connection is done by inserting spike  105  into the IV bag  17  through the IV bag first port  18 . 
         [0138]    The illustration also shows a control unit wireless communication subsystem  220  which can be a little chip on a board of the microcontroller  208 , and whose role will be explained in the description of  FIG. 15 . 
         [0139]      FIG. 8  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , showing its components in a state in which flow is impossible, according to the present invention. The connection of the smart valve  100  to the IV bag  17 , as described for the previous illustration, creates movement in the direction of the arrow up as shown in the illustration, which indicates movement of the moveable assembly  107  relative to the immovable assembly  108 , and therefore the lock pin  116 , which is part of the immovable assembly  108 , in motion pushes the lock  115  towards the lock hook  114 . The lock hook  114  enables lock  115  to pass it, but does not enable its return. In this state, the internal tubule  112  is completely pressed in pressure zone  117  so that no fluid can flow through pressure zone  117 . 
         [0140]    The drop controller means plane  118 , which is at the end of the drop controller means  109 , is fully closed. Namely, as shown in this illustration, the smart valve  100  is closed, and there is no dripping or continuous flow through the internal tubule  112 . 
         [0141]    The need for two modes of the lock hook  114  is a result of the requirement that during prolonged storage no force will be applied to the internal tubule  112 , so that it is not damaged. 
         [0142]      FIG. 9  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , showing the state of its components after locking, according to the present invention. While the moveable assembly  107  remains attached to the IV bag first port  18  when the immovable assembly  108  moves back to its original position, down, as shown by the arrow in the illustration, the lock  115  remains closed, the lock pin  116  also returns to its original state, as shown in the illustration, and the drop controller means plane  118  also remains closed. 
         [0143]      FIG. 10  is a schematic side view illustration of an exemplary embodiment of a smart valve  100  which is connected to IV bag  17  prior to connection to a control unit  200 , according to the present invention. The connection of the control unit  200  to the smart valve  100 , is by engaging the control unit to smart valve connector  204  with the smart valve to control unit connector  106  when moving the control unit  200  right, as shown by the arrow in the illustration. 
         [0144]      FIG. 11  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , which is connected to a control unit  200 , according to the present invention. The present illustration shows the state of the components of the smart valve  100  and the control unit  200 , shown only in part, in the first stage of their connection process, while the control unit  200  moves right, as shown by the arrow in the illustration. 
         [0145]    In this first stage the control unit lock  212  slides towards the locking wall  119  and the locking shaft  216  is in a state of “spring wound” toward the drop controller means  109 . 
         [0146]    The optical transmitter  210  is facing the transmitter light guide  110 , and the optical receiver  211  is facing the receiver light guide  111 . 
         [0147]    The smart valve  100  is in closed mode, which prevents dripping or continuous flow through the internal tubule  112 , by means of the lock  115 . 
         [0148]      FIG. 12  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , which is connected to a control unit  200 , according to the present invention. This illustration shows the state of the components of the smart valve  100  and the control unit  200 , which is shown in part, in the second stage of their connection process. 
         [0149]    In this second stage, the control unit  200 , with further movement to the right, in the direction of the arrow shown in the illustration, is locked to the smart valve  100 . The control unit lock  212  goes through the locking wall  119  and is locked onto it. The locking motion of the lock  212  is an angular movement which can be generated by a spring, not shown in the illustration: while in this case, the lock  212  has freedom of angular movement around an axis near its left end, or by means of elasticity of the locking wall  119 . In this case, it is harnessed at its left end, or with any other suitable device. 
         [0150]    At this point, the engagement of the locking shaft  216  with the drop controller means  109  starts, similar to the engagement of a screwdriver with the head of a screw, while the locking shaft  216  is rotated by the step motor  206  and pressed to the right for the purpose of engagement by the spring  217  for no more than one full revolution until the engagement is complete. At the end of this second stage, passage of fluid through the internal tubule  112  is not possible. 
         [0151]      FIG. 13  is a schematic perspective view illustration of an exemplary embodiment of a smart valve  100 , integrated with control unit  200  and connected between an IV bag  17  and the infusion tubule  20 , according to the present invention. 
         [0152]    The hand-held computer  300  scans the infusion bag barcode sticker  10 , by means of IR radiation  40 , or by means of any other suitable radiation such as RFID, and compares the code entered into hand-held computer  300  and the scanned code, which is entered into its memory. 
         [0153]      FIG. 14  is a schematic perspective view illustration of an exemplary embodiment of a smart valve  100 , integrated with control unit  200  and connected between an IV bag  17  and the infusion tubule  20 , according to the present invention. 
         [0154]    The hand-held computer  300  scans the wristband patient barcode  21  by means of IR radiation  40 , or any other suitable radiation such as RFID, and compares the code entered into it with the wristband patient barcode  21  which is scanned and entered into its memory. 
         [0155]      FIG. 15  is a schematic perspective view illustration of an exemplary embodiment of a smart valve  100 , integrated with the control unit  200  and connected between an IV bag  17  and the infusion tubule  20 , according to the present invention. 
         [0156]    After scanning the infusion bag barcode sticker  10  and the wristband patient barcode  21 , duplex wireless communication  41  is established between the hand-held computer  300 , and the control unit  200 . If all of the data is authenticated, the hand-held computer  300  enables control unit  200  to continue as activated. 
         [0157]    The duplex wireless communication  41  is maintained by a control unit wireless communication subsystem  220  and a hand-held computer wireless communication subsystem  304  which can be a little chip on a board of the hand-held computer  300 . 
         [0158]    The hand-held computer  300  is capable of transmitting all of the data, such as time, dosage, and quantity data, through the wireless communication  41 . 
         [0159]    During its entire process, the control unit  200  transmits data regarding the dripping rate and quantity at any given time. When the required dose is given, or according to any other criterion, the control unit  200  sends an end message to hand-held computer  300  and all of the data is registered in real time. 
         [0160]      FIG. 16  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , which is connected to a control unit  200 , according to the present invention. This illustration shows the state of the components of the smart valve  100  and the control unit  200 , shown only in part, at a stage in which they cannot be disconnected from each other, and a process of dripping sensing is started. 
         [0161]    The optical transmitter  210  transmits its transmission signals as an AC light wave in order to prevent background light interference. The light waves pass through the transmitter light guide  110  and because there is no dripping, the amount of light that returns to the receiver light guide  111  is minimal and does not exceed the threshold necessary for recognizing a proper signal level. 
         [0162]    The transmitted light ray  120  hits the wall of the dripping chamber  103 . 
         [0163]    The transmitted light ray  120  hits the wall at angle {acute over (α)} relative to the perpendicular to the wall and is reflected, as a reflected light ray  121 , at angle {acute over (α)}, with the perpendicular serving as a symmetry line, all practically on the same plane. 
         [0164]    Note: the light ray may be reflected from the wall, however the reflection is minimal due to the acute angle. 
         [0165]    The reflected light ray  121  in the above described situation is not directed such that it can enter the receiver light guide  111 , and thus provides a signal, which is minimally under threshold, for reception by the optical receiver  211 . 
         [0166]      FIG. 17  is a schematic perspective view illustration of an exemplary embodiment of a smart valve  100 , integrated with a control unit  200  and connected between an IV bag  17  and the infusion tubule  20 , according to the present invention, during adjustment of the control unit  200 . The adjustment is achieved by entering data into keyboard  203  and receiving results on display  202 . After the control unit  200  activates the smart valve  100 , the flow of fluid is enabled, and fluid drops  30  begin to appear in dripping chamber  103 . 
         [0167]      FIG. 18  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , connected to a control unit  200 , according to the present invention. 
         [0168]    The present illustration shows the state of the components of the smart valve  100  and the control unit  200 , shown only in part, at the stage in which the control unit  200  recognizes drops. The recognition of drops occurs when the course of the light, as described in  FIG. 16 , changes when a fluid drop  30 , which goes through the transmitted light ray  120 , is disposed in a suitable geometrical location. The fluid drop  30  reflects the light such that the reflected light ray  121  enters the receiver light guide  111 , and is received through it in the optical receiver  211 . The microcontroller  208  calculates the elapsed time between two consecutive fluid drops  30  and activates the step motor  206  for the purpose of opening or closing, if required, according to the data entered in the keyboard. 
         [0169]    The microcontroller  208  uses closed loop control, and during the entire time of activation monitors the state of the step motor  206 , which controls movement to the left and right (relative to the illustration plane) of the drop controller means plane  118 . 
         [0170]    This is achieved also by means of rotating the integral screw  122 , which is an integral part of the locking axis  216 . Closing the integral screw  122  will reduce the flow rate, which as noted is a dripping rate, while opening it will increase the rate. 
         [0171]      FIG. 19  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , connected to a control unit  200 , according to the present invention. 
         [0172]    The present illustration shows the state of the components of the smart valve  100  and the control unit  200 , shown only in part, at the stage in which the control unit  200  is constantly monitoring the dripping rate. As soon as the dripping stops, for any reason, for longer than a given time, such as 30 seconds, the control unit  200  closes the smart valve  100  hermetically, and the display  202  displays a message such as “The system can be disconnected”. Disconnection is performed by pulling switch  205  to the left, as shown by the arrow in the illustration, causing the step motor  206  to start rotating to opening position, the cam  218  is in the upper position in the end of the switch  205  position. The step motor  206  rotates by 180 degrees and the cam  218  pushes the control unit lock  212  down. The position of the switch  205  is monitored by cutoff detectors, not shown in the illustration, causing the release of the locking shaft  216  from the drop controller means  109  and the automatic activation of the step motor  206  to open state of the control unit lock  212 . Opening the control unit lock  212  is performed by pressing cam  218 , which is connected to locking shaft  216 , towards the locking wall  119 , enabling the disconnection of the control unit lock  212  from the smart valve  100 , causing the release of locking shaft  216  from the drop controller means  109 . 
         [0173]      FIG. 20  is a schematic side view illustration of an exemplary embodiment of a smart valve  100 , connected between an IV bag  17  and the infusion tubule  20 , according to the present invention, in the stage following disconnection from the control unit  200 . 
         [0174]    The control unit  200  is in closed mode, the drop controller means plane  118 , and the control unit lock  212  is in open mode and enables further activation (with another smart valve  100 ). 
         [0175]    While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made, such as designing drop controlling and counting valve on key system  1000  in various configurations, for example in order to obtain the desired position of the center of gravity by changing the positions of various components and even adding balancing weights.