Abstract:
It is a primary object of the present invention to provide an automated system based on an integral fluid bag for administering a variety of intravenous drug regimens and reducing the vagaries of existing manual systems. The fluid has multiple chambers configured to implement a prescribed intravenous medical therapy. Each chamber&#39;s geometry (size, shape), sequence and position, alone and in combination with the other chambers, matches the prescribed intravenous therapy or drug regimen. The bag&#39;s configuration assures that the intravenous therapy is administered in accordance with the prescribed drug regimen, thus automating the previous manual method. A choice of fluid bag configurations may be stocked so that a prescription for well known and widely accepted drug regimens may be filled by merely selecting a bag with the appropriate chamber configuration and filling it with the prescribed medications.

Description:
FIELD OF THE INVENTION  
         [0001]    The invention relates generally to apparatus and methods for the intravenous infusion of medication and, more particularly, to the automatic administration of intermittent medications in accordance with a predetermined medical therapy. A multichamber fluid bag is manufactured with a particular chamber size and geometry for implementing a prescribed infusion therapy. Because the infusion therapy is implemented by the bag&#39;s chamber configuration, the administration of a complex medical infusion therapy is simplified.  
         BACKGROUND OF THE INVENTION  
         [0002]    It is now common for intravenous medications such as antibiotics, antivirals, antiemetics, chemotherapy and biotechnology drugs to be administered intermittently with a frequency as often as multiple times per day. Depending on the frequency of administration, the patient is either repeatedly connected to and disconnected from an intravenous (I.V.) line or is continuously connected to an I.V. line between administrations. In either case, the intermittent medications are generally administered by trained personnel using predefined procedures that often include a series of manual steps and a large number of disposable supplies. Each manual step in these procedures increases the risks associated with multiple manipulations and entry of I.V. sites.  
           [0003]    The predefined procedures attempt to ensure the proper administration and the proper dosing of medication, while preventing incompatibilities between different drugs and preventing I.V. lines from clotting off between doses. Unfortunately, because of the manual steps included in these procedures, they have not been entirely successful in guaranteeing that medications are administered in the correct sequence, at the correct infusion rates, and in the correct volumes. Further, if the appropriate procedural steps are not performed within the required time frames, clots may form in the I.V. lines. Also, the manual steps included in these administration procedures are the principle source of infection and other complications that may arise during intermittent infusion therapy. Such problems and complications result in a longer hospital stay for the affected patient. Recent trends which have the patient trained to administer their own medications at home only exacerbate the problems and risks associated with intermittent infusion therapy. Further, elaborate or complicated infusion procedures are more likely to give rise to patient non-compliance by an untrained and less sophisticated home infusion patient.  
           [0004]    One prevalent example of home health care therapy is the delivery of antibiotics and other medications utilizing the SASH protocol. SASH is an acronym that stands for Saline-Antibiotic-Saline-Heparin. The patient is trained to follow the SASH protocol by first attaching a saline filled syringe to the catheter to flush and clear the line. The patient then attaches a second syringe filled with the desired medicine or the patient attaches an IV set connected to a minibag, or other container, to the catheter and the medicine is delivered to the patient. A third syringe filled with saline is then attached to the catheter and the saline is injected to clear the line of all medication. Finally, a last syringe is attached to the catheter line and a heparinized solution is injected into the line to keep the line open and maintain the patency of the line for the next time a medication needs to be delivered.  
           [0005]    The SASH system is currently delivered to the patient in two ways. In the first way the patient is given syringes, needles and vials of saline, medication, and heparin and the patient is instructed how to use the tools. In the second way, pre-filled syringes are supplied to the patient and instruction is provided.  
           [0006]    The normal SASH procedure is to clear the line with a small injection of saline, administer the desired medication, clear the line again with another small injection of saline and then to inject heparin in the line to maintain patency of the IV site. The final injection of heparin into the IV site prevents coagulation in the line until the next administration of medication. Each of the fluids in the sequence is injected with a separate syringe with the only possible exception being the medication which may be delivered through an IV set.  
           [0007]    Some medications require a relatively long period of time to inject because they will cause vein irritation or other complications if they are injected too quickly. To avoid this, the medication is diluted into a volume of solution, typically normal saline or DSW, up to 250 cc&#39;s. The infusion time can take in excess of 60 minutes.  
           [0008]    The above procedures involve the use of multiple syringes and needles, vials of saline and heparin and an IV drip set for medications that must be administered over a relatively long period of time. In this instance, the patient is connected to an IV drip after the initial line clearing injection of saline. When the IV drip is finished, the line is again cleared with saline from a syringe and the heparin is injected to maintain the patency of the line. The patient, nurse or pharmacist must fill the syringes from the vials for each of the injections and the needles used in the procedure must then be disposed of in a safe manner.  
           [0009]    In addition to the sequential delivery of medications described above as the SASH process, patients frequently receive multiple medications. In some situations, these medications cannot be premixed until just prior to delivery to the patient.  
           [0010]    Therefore it would be of great advantage to have a delivery system for multiple medications that does not involve the use of multiple syringes and needles. It would also be an advantage to have a medication delivery system that could be pre-filled with the correct volume of medication or multiple separate medications and which could be administered by the patient automatically in the correct sequence and/or concurrently over the desired time period. A desirable medication delivery system would be extremely simple to use, low in cost and could then be discarded without the usual concerns over the disposal of medical waste.  
           [0011]    Accordingly, there exists a definite need for apparatus, devices and related methods for simplifying the administration of intermittent medical infusion therapy. The present invention satisfies these needs.  
         SUMMARY OF THE INVENTION  
         [0012]    The present invention is embodied in a fluid delivery apparatus for the automated sequential or concurrent infusion of a plurality of pharmacological agents. The apparatus includes a plurality of chambers each configured with a respective geometry. Each chamber configuration controls the regimen with which said pharmacological agents are administered by controlling, e.g., the volume and the rate at which each pharmacological agent is administered.  
           [0013]    The present invention provides an automated system for administering a variety of known drug regimens, thus eliminating the problems associated with the manual infusion system. Because the system uses an intravenous bag having multiple chambers with particular configurations, the contents of the bag can only be administered in accordance with the prescribed manner.  
           [0014]    The fluid delivery apparatus may further include a common passageway and a plurality of chamber passageways. Each chamber passageway is coupled between the common passageway and a respective chamber. The fluid delivery apparatus may also include a high pressure clip having at least first and second positions, wherein, in the first position, the clip closes the plurality of chamber passageways and, in the second position, the clip permits fluid flow through the plurality of chamber passageways. The apparatus may also include a pressure sensing dome in fluid communication with the common passageway. Further, a frangible rupture seal may be situated between at least one chamber and the corresponding chamber passageway. Also, at least one chamber includes a sealable fill port and a sealable vent port.  
           [0015]    The fluid delivery apparatus may further include an infusion pump with a spring driven roller for sequentially compressing the plurality of chambers. The pump may include a hinged door having a release tab. Alternatively, infusion pump may be actuated by an electrically driven motor for applying pressure to the chambers. The infusion pump may further include a display having status indicator lights, dose buttons, control buttons, a keypad, and a clock for controlling and indicating the status of administration of an agent.  
           [0016]    Alternatively, the infusion pump may have one or more inflatable bladders for applying pressure to the chambers. Further, a flexible bladder pad may be coupled to a series of bladders for transferring pressure from the series of bladders to the chambers and locally distributing the force applied by any one of the series of bladders.  
           [0017]    In an alternative embodiment, the invention is embodied in a fluid bag that is to be filled with pharmacological fluids associated with a desired medical infusion therapy for treatment of a patient. The bag has a plurality of chambers (which typically lie substantially in a plane) for containing the pharmacological fluids. Each chamber is sized and configured to implement the desired medical therapy when the fluids are automatically infused into the patient. The bag may be a unitary bag forming a cartridge.  
           [0018]    In yet another embodiment, the invention is embodied in an automated fluid delivery apparatus for sequentially or concurrently infusing medications. The apparatus includes a fluid bag which is constructed from medical grade plastic sheets that are bonded together in a manner to define a plurality of separate chambers. The chambers lie in a plane and are configured with a respective geometry, position, and sequence for controlling the rate, volume and time of medication administration.  
           [0019]    The invention is also embodied in a preassembled and easy to use cartridge for in-home patient use that will minimize patient mistakes and the amount of time needed for training the patient. The cartridge can be inserted in a rate controlled pump that will allow the slow administration of single or multiple medicines such as antibiotics or other drugs that can only be combined upon infusion.  
           [0020]    The cartridge is contructed of two pieces that have been sealed together to form liquid containing chambers. Each chamber has a port for filling the respective chambers with the desired type and volume of fluid. For the SASH procedure, for example, the chambers would normally be filled in order with Saline, Antibiotic, Saline and then Heparin. At the exit port for each chamber is a one way check valve to prevent backflow into the chamber. Each chamber empties into a common dispensing line. A clamp can be used to close the dispensing line. A standard medical connector, such as a luer lock, heparin lock or needle is used to connect the cartridge to the patient&#39;s IV set or catheter.  
           [0021]    Different geometric configurations of the chambers can be used for controlling and varying the rate of flow. The geometry of the chamber can also be configured for a constant flow and to minimize the retention of residual fluid in the chamber.  
           [0022]    In one aspect of the invention, a cartridge, with 4 chambers, is placed in a rectangular hopper. The cartridge is fed through rollers and fluid is squeezed out of the cartridge through an injection line. The rollers are driven by a motor which drives a shaft that drives the rollers. A clutch is used to limit the maximum amount of force that can be applied to the rollers.  
           [0023]    In an alternative embodiment of the invention, there is only one roller that is held and guided by slots to roll over the cartridge. The roller is biased by a spring to roll over the cartridge and inject the fluids in the desired sequence. This embodiment can also use a motor and worm gear to drive the roller over the cartridge to dispense the fluid in the cartridge.  
           [0024]    The features of the present invention are set forth with particularity in the appended claims. The invention will best be understood from the following description when read in conjunction with the accompanying drawings.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0025]    [0025]FIG. 1 is a plan view of a fluid bag, according to the invention, having chambers with geometries configured for implementing a medical infusion therapy.  
         [0026]    [0026]FIG. 2 is a side elevation view of the fluid bag of FIG. 1.  
         [0027]    [0027]FIG. 3 is a plan view showing a cut and weld pattern for the fluid bag of FIG. 1.  
         [0028]    [0028]FIG. 4 is a top view diagram of a cartridge of the present invention.  
         [0029]    [0029]FIGS. 5, 6,  7  and  8  are alternate configurations of the fluid reservoir.  
         [0030]    [0030]FIGS. 9 and 10 are diagrams used to illustrate the method of calculating the flow rate for a particular reservoir shapes.  
         [0031]    FIGS.  11 A- 11 F are schematic diagrams showing various chamber configurations, according to the invention, for the fluid bag of FIG. 1, each diagram showing a specific chamber configuration with chamber geometries configured for implementing a prescribed medical infusion therapy.  
         [0032]    [0032]FIG. 12 is a top view of another embodiment of the cartridge of the invention.  
         [0033]    [0033]FIG. 13 is a plan view of a fluid bag having a high pressure clip and a low pressure clamp pad for controlling fluid flow from the chambers.  
         [0034]    FIGS.  14 A- 14 C are elevation side views of the fluid bag of FIG. 13, showing the exit port clip in its pre-installation, open, and closed positions, respectively.  
         [0035]    FIGS.  15 A- 15 D are isometric views of a fluid bag, according to the invention, having an integral fluid port, pressure monitoring pad, and port clip.  
         [0036]    [0036]FIG. 16 is an elevation view of a fluid bag, according to the invention, having frangible seals.  
         [0037]    [0037]FIGS. 17A and 17B are perspective views of an infusion pump, according to the invention, having a chamber configured to receive the fluid bag of FIG. 1 and opposing rollers for infusing the fluids contained in the respective chambers in a prescribed sequence and rate defined by the bag chamber geometries and roller speed.  
         [0038]    FIGS.  18 A- 18 C are plan and side elevation views, respectively, of the infusion pump of FIGS. 17A and 17B, having an installed infusion bag.  
         [0039]    [0039]FIGS. 19A and 19B are schematic diagrams showing control panel layouts for two embodiments of the infusion pump of FIGS. 17A and 17B.  
         [0040]    [0040]FIG. 20 is a schematic diagram of an inflatable bladder, according to the invention, having an inflation control belt for use in an infusion pump to sequentially empty a fluid bag.  
         [0041]    [0041]FIG. 21 is a schematic diagram of a plurality of inflatable bladders, according to the invention, for use in an infusion pump to sequentially empty a fluid bag.  
         [0042]    [0042]FIG. 22 is a schematic diagram of a plurality of inflatable bladders, according to the invention, that act against a flexible pad for use in an infusion pump to sequentially empty a fluid bag.  
         [0043]    [0043]FIG. 23 is a schematic diagram of an inflated bladder, according to the invention, for use in an infusion pump having active valves for controlling the fluid flow from each chamber to sequentially empty a fluid bag.  
         [0044]    [0044]FIG. 24 is a diagram showing the cartridge in a pump mechanism embodiment of the present invention.  
         [0045]    [0045]FIG. 25 is a diagram showing the cartridge in an alternate pump mechanism of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0046]    The present invention is embodied in apparatus and related methods for automatically implementing intermittent intravenous medical therapy using a fluid bag having a configuration that largely defines the sequence and flow rate of the infusion of medications into a patient. The invention is advantageous in simplifying the administration of intermittent intravenous medical infusion therapy. A patient (or caregiver), with relatively little medical training, would receive a fluid bag having chambers configured with predetermined geometries and prefilled with prescribed medications and would self-administer the therapy using an infusion pump. Because the therapy is defined by the bag&#39;s configuration, the patient, nurse or caregiver would not need to program the infusion pump or perform manual manipulations during the infusion procedure thus substantially reducing the patient&#39;s risks due to improper administration.  
         [0047]    Referring to FIGS. 1 and 2, the invention is embodied in a multiple chamber fluid bag  20  or cartridge having a plurality of fluid chambers  22 ,  24 ,  26  and  28 . The bag is a laminate of two flexible plastic sheets attached together to form four separate and distinct chambers and corresponding passageways (not shown) from each chamber to a common passageway  30  and an exit port  31 . The unitary bag is relatively flat with the chambers generally lying in a common plane. When chambers are filled with fluid, they expand to have a cylindrical or a “pillow-like” shape. An infusion tube  32  is coupled to the exit port. A connector  34  is coupled to the tube for connection to standard I.V. couplers. A clip  36  is provided on the tube to stop fluid flow through the tube if needed. Although four chambers are shown in FIG. 1., as will be discussed in more detail below, the fluid bag may be configured with any of a wide variety of chamber numbers, positions, sequences, and geometries. Each chamber may also include one or more fill ports  38  for filling the chambers. The bag may also include alignment holes  40  (or other alignment vehicles) for positioning the bag within an infusion pump having corresponding alignment pegs (not shown).  
         [0048]    The chambers  22 ,  24 ,  26  and  28  may be emptied by applying pressure to the bag  20 . As discussed below with respect to FIGS. 24 and 25, the pressure may be applied by a roller traveling from the top of the bag toward its bottom at a steady rate. Other apparatus and methods for applying pressure to the chambers are also discussed in more detail below with respect to FIGS.  17 - 23 .  
         [0049]    The chambers of the fluid bag  20  of FIGS. 1 and 2 are suitably configured to implement a SASH infusion therapy. SASH is an acronym for Saline-Antibiotic-Saline-Heparin. The first chamber  22  is typically filled with about 5 ml. of saline solution. The second chamber  24  is typically filled with about 100 ml. of liquid antibiotic. The third and fourth chambers are each typically filled with about 5 ml. of saline solution and heparinized solution, respectively.  
         [0050]    With reference now to FIG. 3, the bag  20  can be constructed from two flexible sheets of plastic film  44  by welding the sheets together along weld lines  46 . The welds may be ultrasonic or heat welds or the like. The weld lines define each chamber&#39;s geometry and size thus its volume. The geometry and volume of each chamber defines the sequence and rate at which the corresponding prescribed medication is infused into the patient. The four alignment holes  40  may be cut before or after the sheets are welded. The plastic film may be formed of any medically acceptable plastic, e.g., polyvinyl chloride (PVC), polyolefin or other suitable material.  
         [0051]    The rate at which the medications exit the chambers may be additionally defined by restrictive openings at the exit of each chamber, e.g., by a restrictive orifice in the common passageway  30 , by a valve in the infusion tube  32 , or the like. Exit port openings for controlling the flow rate from the chambers are discussed below in more detail with respect to FIG. 9.  
         [0052]    [0052]FIG. 4 shows a top view of a cartridge  310  of the present invention. The cartridge  310  has four chambers  312 ,  314 ,  316  and  318  for holding the SASH fluids. The first chamber  312  holds 3-10 cc&#39;s of saline solution. The second chamber  314  holds 10-250 cc&#39;s of the desired medicine. The third chamber  316  holds 3-10 cc&#39;s of saline and the forth chamber  318  holds 3-10 cc&#39;s of heparin. The first chamber  312  is filled via port  332 ; the second chamber  314  is filled via port  334 ; the third chamber  316  is filled via port  336  and the fourth chamber  318  is filled via port  338 . Ports  332 ,  334 ,  336 , and  338  are standard injection ports or luer lock connections. Chambers  312 ,  314 ,  316  and  318  are supplied factory pre-filled or are pre-filled by a pharmacist with the correct fluids. After the ports are filled by the pharmacist they are sealed by the self sealing injection port or by a cap on the luer lock connection. If the chamber is factory pre-filled, it may be heat sealed after filling which would eliminate the need for an inlet port. At the exit port of each chamber is a check valve that only permits fluid flow in one direction. Check valves  322 ,  324 ,  326  and  328  are at the exit ports of chambers  312 ,  314 ,  316  and  318 , respectively. Each check valve permits fluid flow into line  330  as shown in FIG. 4. Line  330  passes through clamp  340  that is used to completely restrict any fluid flow. Line  330  terminates at luer connection  342  that is used to connect to the patient catheter.  
         [0053]    The cartridge  310  is constructed as a two piece laminate made from PVC, polyolefin or similar materials typically used for IV bags. The laminate is heat sealed or adhesively bonded. The cross-hatched areas  320  show the sections of the cartridge  310  that have been bonded together. The unbonded areas are represented by the chambers  312 ,  314 ,  316  and  318 . The chambers can be made in many different geometric shapes. These shapes can be used to control the flow rate of the medication in the chambers. This will be discussed with reference to FIGS. 9 and 10.  
         [0054]    When the chambers have been filled with the desired fluids, the cartridge  310  is placed in the pump unit, not shown in FIG. 4, for infusion of the medication. Rollers will squeeze the fluids in sequence from chambers  312 ,  314 ,  316  and  318  into the line  330 , past the clamp  340  to luer connection  342  and into the patient catheter. When the infusion sequence is completed, the cartridge can be disconnected from the catheter and pump and then discarded. This infusion process does not involve the use of needles or syringes and therefor increases the safety factor for anyone administering the procedure. The fluid dynamics of the dispensing process will now be discussed with reference to FIGS.  5 - 10 .  
         [0055]    [0055]FIGS. 5, 6,  7  and  8  show alternate geometric shapes for the fluid chambers discussed with reference to FIG. 4. FIG. 5 shows a fluid chamber  350  having a filling port  356  and an exit port  352 . As fluid chamber  350  is compressed by the pumping device, to be discussed later, the fluid is expelled from the chamber  350  through the exit port  352 . The shape of chamber  350  can provide a higher fluid flow rate in the beginning and a steadily decreasing flow rate until all the fluid has been dispensed. The fluid flow rate will be discussed in greater detail with reference to FIGS. 9 and 10. FIG. 6 shows fluid chamber  354 , filling port  358  and exit port  355 . The shape of this fluid chamber can provide a constant fluid flow rate from the beginning to the end of the infusion. FIG. 7 shows fluid chamber  360  with filling port  64  and exit port  362 . The shape shown in FIG. 7 can provide a nonlinear decrease in the flow rate from the beginning to the end of the infusion. FIG. 8 shows fluid chamber  366  having filling port  368  and exit port  365 . The shape shown in FIG. 8 can provide an initially constant fluid. flow rate followed by a steadily decreasing flow rate during the last part of the infusion. The factors involved in determining the fluid flow rate will now be discussed with reference to FIGS. 9 and 10.  
         [0056]    [0056]FIG. 9 shows a fluid chamber  370  having an exit port  372 . The exit port  372  has a length represented by L and a radius represented by R. P 1  represents the pressure inside the fluid chamber  370  and P 2  represents the pressure outside the fluid chamber  370 . In the following formula Q represents the Mass Flow Rate in ml/min and u represents the viscosity of the fluid in the fluid chamber  370 . The formula is as follows: 
           Q=πR   4 ( P   1   −P   2 )/8 Lu   
         [0057]    The above equation is Poiseville&#39;s Law for Homogeneous Fluid. P 1 −P 2  is the difference in pressure between the inside and the outside of the fluid chamber  370 . A change in the radius R of the exit port  372  or a change in the length L of the exit port  372  can have a large effect on the flow rate Q. The elasticity of the materials used to construct the fluid chamber can also have an effect on the flow rate. However, for the purpose of this discussion it is assumed that the elasticity will not have a significant effect on the flow rate.  
         [0058]    [0058]FIG. 10 shows a fluid chamber  380  having an exit port  386 . If it is assumed that the R and L are constant, then the major factor in determining the flow rate will be P 1 . If a press type roller moving at a constant rate starts to compress the fluid chamber  380  at point  388  then the pressure P 1  will continually increase. Thus the pressure generated at line  384  will be much greater than the pressure generated at line  382 , causing a much higher flow rate at line  384 . FIG. 10 shows a fluid chamber that can have an increasing flow rate from the beginning to the end of the infusion.  
         [0059]    Differing infusion therapies for a wide variety drug regimens may be implemented by the chamber configurations as shown, for example, in FIGS.  11 A- 11 F. For example, as shown, in FIG. 11A the infusion bag  20  is configured with four separate fluid chambers  22 ,  24 ,  26  and  28  suitable for implementing a SASH drug regimen. The intravenous antibiotic is contained in the second chamber  24 . The volume and shape of the second chamber may be prescribed to affect the volume and the administration rate of the antibiotic as shown in FIGS.  11 A- 11 C. In FIG. 11A, the antibiotic chamber  24  has a square shape and a volume of about 100 ml. In FIG. 11B, the antibiotic chamber  24  has an elongated rectangular shape and a volume of about 50 ml. The antibiotic chamber  24  shown in FIG. 11C, also has a volume of 50 ml, but has a wide shortened rectangular shape. Accordingly, using a constant speed roller that compresses the chambers from top to bottom, the drug prescribed by the bag in FIG. 11B is infused at a slower rate than the drug prescribed by the bag in FIG. 11C. The chamber, of course, is not required to have a rectangular shape and, thus, it may have any shape (e.g., circular, triangular, diamond, etc.) which is beneficial for administering a prescribed infusion therapy.  
         [0060]    Further, drugs that are incompatible for pre-mixing may be stored in separate chambers until they are simultaneously infused into the patient. As shown in FIG. 11D, simultaneous infusion of separate drugs may be readily accomplished by configuring the bag  48  to have two side-by-side chambers  50  and  52 . The first chamber  50  is filled with a first drug and the second chamber  52  is filled with a second drug. Accordingly, as the roller travels down the bag, it simultaneously compresses the two side-by-side drug chambers so that the two drugs are simultaneously infused into the patient, thus simplifying the infusion of the two incompatible drugs without pre-mixing.  
         [0061]    As shown in FIG. 11E, the infusion therapies that may be addressed by configuring the bag&#39;s geometry are not limited to the SASH procedure. The bag in FIG. 11E is configured with six separate chambers. The first, third and fifth chambers  56 ,  58  and  60  can be filled with a saline solution and the sixth chamber  62  can be filled with Heparin. The second and fourth chambers  64  and  66 , however, can be filled with first and second drugs, respectively. Of course, this bag may be used to administer intermittent infusions of a single drug by filling the second and fourth chambers with the same drug.  
         [0062]    Similarly, as shown in FIG. 11F, multiple doses of a drug may be intermittently administered at prescribed time intervals by a bag  70  having its chambers configured in accordance with the dosage regimen. Thus, the first chamber  72  can be filled with a first prescribed drug dosage, the second chamber  74  can be filled with a saline solution, the third chamber  76  can be filled with a second prescribed drug dosage, the fourth chamber  78  can be filled with a saline solution, the fifth chamber  80  can be filled with a third described drug dosage, and finally, the sixth chamber  82  can be filled with a final saline solution.  
         [0063]    [0063]FIG. 12 shows a cartridge  440  having six fluid chambers  454 ,  456 ,  458 ,  460 ,  462  and  464 . Each fluid chamber has its respective check valve  468 ,  470 ,  472 ,  474 ,  476  and  478  in its respective exit port. Each of the fluid chambers  454 ,  456 ,  458 ,  460 ,  462  and  464  is filled via its respective filling port  442 ,  444 ,  446 ,  450 ,  448  and  452  as previously described. The exit port for each fluid chamber empties into line  466  causing the fluid in the chambers to pass along line  466  through clamp  480  to luer connector  482 . The connector  482  can be any type of connector required for the environment in which the cartridge  440  is used. Fluid chamber  454  could be used to deliver saline as previously discussed. Chambers  456 ,  458 ,  460  and  462  would be used to deliver medications concurrently to the patient. For instance, fluid chambers  456  and  458  will deliver the medications concurrently with both chambers starting delivery and ending delivery of the medication at the same time. Fluid chamber  462  will start its delivery after fluid chambers  456  and  458  start their delivery and fluid chamber  462  will end its delivery of medication after fluid chambers  456  and  458  end their delivery. Fluid chamber  460  will begin its delivery of medication before fluid chambers  456 ,  458  and  462  deliver their medication and fluid chamber  460  will end its delivery of medication after fluid chambers  456 ,  458  and  462  end their delivery of medication. This arrangement allows the flexibility of delivering medications simultaneously or in any sequence desired. This is useful when medications that cannot be premixed are to be delivered simultaneously. In another sequence, fluid chamber  460  can be filled with saline that can be delivered simultaneously with and after the medications that are delivered from the fluid chambers  456 ,  458  and  462 . Fluid chamber  464  could then contain heparin as previously discussed. The cross-hatched areas  484  show the sections of the cartridge  440  that have been bonded together. This arrangement shows the flexibility of the invention as well as the simplicity of the invention that allows for the uncomplicated administration of medications to a patient.  
         [0064]    Intermittent medications are prescribed using widely accepted medical infusion therapies that are fairly standard for adult patients with similar diagnoses. These standard medical therapies often call for multiple administrations of an infusion regimen each day and rarely change after they are prescribed. Thus a prescription for an infusion regimen is similar to a prescription for an oral antibiotic in that the drug is taken a predetermined number of times per day for a predetermined time period. Accordingly, an infusion patient generally receives a prescription for a particular medical infusion therapy that remains the same for several days. In accordance with the invention, the infusion prescription is filled by a pharmacist having a supply of infusion bags  20  having chambers with differing configurations. The pharmacist would provide the patient with the prescribed number of prefilled bags with the prescribed medication dosages.  
         [0065]    The following list is illustrative of the types of drug regimens that may be implemented in a bag in accordance with the invention. Possible drug regimens and possible chamber configurations are not limited to those listed below or shown in the drawings.  
       Partial List of Example Drug Regimens  
     Antibiotics  
       [0066]    1)  
         [0067]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0068]    1 gram (g) of Cefazolin in 50 ml of 5% Dextrose in Water—given over 60 minutes; and  
         [0069]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0070]    2)  
         [0071]    3 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0072]    1 g of Cefazolin in 20 ml of Dextrose (D5W)—given over 30 minutes;  
         [0073]    3 ml of 0.9% Saline—given quickly or over a few minute;  
         [0074]    1 g of Ceftazidime in 20 ml of Dextrose (D5W)—given over 30 minutes;  
         [0075]    3 ml of 0.9% Saline—given quickly or over a few minutes; and  
         [0076]    5 ml of 1000 units/mL of Heparized Saline—given quickly or over a few minutes.  
         [0077]    3)  
         [0078]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0079]    80 mg of Gentamicin in 50 ml of 0.9% Saline—given over 60 minutes;  
         [0080]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0081]    500 mg of Ampicillin in 100 ml of 0.9% Saline—given over 60 minutes;  
         [0082]    5 mls of 0.9% Saline—given quickly or over a few minutes; and  
         [0083]    5 ml of 100 units/ml of Heparized Saline—given quickly or over a few minutes.  
         [0084]    4)  
         [0085]    10 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0086]    1 g of Vancomycin in 250 ml of 0.9% Saline—given over 90 minutes; and  
         [0087]    10 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0088]    5)  
         [0089]    3 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0090]    1 g of Cefazolin in 20 ml of Dextrose (D5W)—given over 30 minutes;  
         [0091]    80 mg of Gentamicin in 50 ml of 0.9% Saline—given over 60 minutes;  
         [0092]    1 g of Ceptazidime in 100 ml of 0.9% Saline—given over 60 minutes; and  
         [0093]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0094]    6)  
         [0095]    500 mg of Cafazolin in 20 ml of Dextrose (D5W)—given over 30 minutes;  
         [0096]    500 mg of Ceptazidime in 20 ml of 0.9% Saline—given over 60 minutes; and  
         [0097]    50 mg of Tobramycin in 50 ml of 0.9% Saline—given over 60 minutes.  
         [0098]    Anti-Emetic (Nausea) Therapy and Chemotherapy  
         [0099]    1)  
         [0100]    100 ml of 0.9% Saline given over 30 minutes;  
         [0101]    Kytril in 20 ml of 0.9% Saline given over five minutes; and  
         [0102]    Cisplatin in 100 ml of 0.9% Saline given over 30 minutes.  
         [0103]    Chemotherapy  
         [0104]    1)  
         [0105]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0106]    25 ml of Cyclophosphamide—given over 30 minutes;  
         [0107]    25 ml of Doxirubicin—given over 5 minutes;  
         [0108]    25 ml of 5-FU—given over 10 minutes; and  
         [0109]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0110]    2)  
         [0111]    10 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0112]    10 ml of Vincristine—given over five minutes; and  
         [0113]    10 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0114]    3)  
         [0115]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0116]    10 ml of 5-FU—given over 10 minutes;  
         [0117]    5 ml of 0.9% Saline—given quickly or over a few minutes; and  
         [0118]    5 ml of 100 units/mL of Heparized Saline—given quickly or over a few minutes.  
         [0119]    Other (Biotechnology Drugs)  
         [0120]    1)  
         [0121]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0122]    30 ml of Drug #1—given over 60 minutes;  
         [0123]    10 ml of Drug #2—given over 20 minutes; and  
         [0124]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0125]    2)  
         [0126]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0127]    30 ml of Drug #1—given over 60 minutes;  
         [0128]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0129]    10 ml of Drug #2—given over 20 minutes; and  
         [0130]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0131]    3)  
         [0132]    5 ml of 0.9% Saline—given quickly or over a few minutes;  
         [0133]    60 ml of Drug #1—given over 60 minutes tapered linearly beginning at a rate of 10 ml/hr and ending at a rate of 110 ml/hr.; p 1  15 ml. of Drug #2—given over 30 minutes; and  
         [0134]    5 ml of 0.9% Saline—given quickly or over a few minutes.  
         [0135]    Another embodiment of a fluid bag  90 , in accordance with the invention, is shown in FIGS. 13, 14A,  14 B and  14 C. In this embodiment, the fluid bag includes a high-pressure clip  92  that is completely closed when the bag is in transport, preventing fluid from leaking from the bag or from moving between chambers. The clip includes a first bar  94  having two notched prongs  96 , and a second bar  98  having two corresponding sockets  100  for receiving the prongs. The bars may also include alignment holes  107  for specifically aligning the clip in the pump. The clip may be formed of metal or relatively rigid plastic and the two bars may be attached by a small wire or flexible plastic strip  101 . The prongs each have a dual position latch  102  which engages a ledge  104  in the socket. After the clip is closed to the second latch position, it closes the passage ways (see FIG. 14C) and cannot be opened with reasonable manual effort. The clip is engaged on the bag over the chamber passageways  108 ,  110 ,  112  and  114  through two clip holes  106  in the bag. The clip is automatically released and opened only when the bag is placed in an infusion pump of the invention, and the pump&#39;s door is properly closed, the latch is automatically opened by the pump to a first open position (see FIG. 14B).  
         [0136]    In this embodiment, the pump also includes a low-pressure clamp. When the bag is properly placed in the pump and the door is properly closed, the low-pressure clamp or pad of the pumping device lays parallel next to the clip and seals off the chamber passageways  108 ,  110 ,  112  and  114  at a pad location  115  and simultaneously the clip is opened. The low-pressure clamp generates sufficient pressure to prevent any fluid flow through the chamber passageways until a minimum of pressure is applied to the chambers by the pump. When the pump generates enough pressure within a chamber, the fluid in the chamber is forced underneath and past the clamp through the corresponding chamber passageway to a common passage  116  which leads to the outlet port  118 . The bag may also include a pressure sensing dome  120  which is fluidly coupled to the common passage. The pressure sensing dome may be used to provide occlusion detection or pressure control. The pump pressurizes the bag in a linear sequence from the bag&#39;s top to its bottom. Again, because each chamber&#39;s size and shape governs how the contents of each respective chamber will be administered, the bag may be configured to match the designed drug regimen.  
         [0137]    In this embodiment, the bag&#39;s chambers can be filled with its base solutions (diluent) through the outlet (and fill) port  108  in the following manner. The high pressure clip  92  is released either by a special filling device which automatically releases the clip as the proper solution(s) are flowing into the bag or by a specially designed hand release device. Additionally, the bag may include filling ports for each chamber (not shown, see e.g., FIG. 1) and fluids or drugs may be added through these filling ports on an opposite side of the bag.  
         [0138]    FIGS.  15 A- 15 D show another embodiment of a fluid bag  122  of the present invention. The bag is shown with four chambers  22 ,  24 ,  26  and  28  for implementing the SASH infusion procedure. In this embodiment, the bag includes an integral connector  124  for coupling to an infusion tube (not shown). The integral connector allows the bag to be more integrated and simplifies the procedure for inserting the bag into an infusion pump. The bag further includes associated passageways  108 ,  110 ,  112  and  114  from each chamber to a common passageway  116  leading to the connector, a high pressure clip  92 , five alignment holes  40 , and a pressure sensing dome  120 . These components function as described in the previous embodiment shown in FIGS. 13 and 14A- 14 C.  
         [0139]    [0139]FIG. 16 shows another embodiment of a fluid bag of the invention. The bag  130  has features that are similar to the features of the bags discussed above and further includes fill openings  132 , vent openings  134  and frangible rupture seals  136 . Thus, each of the chambers  22 ,  24 ,  26  and  28  has a fill opening  132  and a vent opening  134 . The vent part for the drug chamber  24  also includes a resealable or reusable port  138  for adding medication to the chamber.  
         [0140]    In this embodiment, the chambers are filled with the prescribed fluids through the fill openings  132 . Air is allowed to escape through the vent openings  134  to prevent air bubbles in the chambers. Then all of the openings, except the opening to the additional drug port  138 , may be sealed along seal lines  140  and  142  by a heat or ultrasonic seal or the like. An additional seal may seal the drug chamber  24 . The seal prevents the addition of additional drugs to the respective sealed chambers. The bag also features frangible rupture seals. As pressure is sequentially applied to the second, third and fourth chambers, respectively, the seal ruptures when the pressure in the corresponding chamber exceeds a predetermined threshold value. Alternatively, the rupture seals may break at incremental increases in the applied chamber pressure such that when increasing pressure is applied to the entire surface of the bag, the rupture seals define the sequence of administration of the fluids in the chambers.  
         [0141]    The fluid bag of the invention may be filled by the bag manufacturer or by a pharmacist. The manufacturer may fill the bag&#39;s chambers with saline solution, with other base solutions, or with the appropriate medications in a “form, fill and seal” or other manufacturing process. Alternatively, the manufacturer may leave one or more chambers empty. The pharmacist would then complete the prescription using the fill ports. In yet another alternative, medication may be added to a bag through the fill port after the bag is inserted into a pump.  
         [0142]    The techniques for applying pressure to the bag may include a linear roller mechanism, a coiled spring mechanism, an air bladder, a series of platens, or other alternative methods. The pressurization technique is chosen in accordance with the designed embodiment of the bag and may be effected by a mechanical, electrical, chemical or other drive means, alone or in combination. Apparatus for implementing representative pressurization techniques are discussed below.  
         [0143]    [0143]FIGS. 17A and 17B show an embodiment of an infusion pump  150  for expelling the fluids from the chambers  22 ,  24 ,  26  and  28  of a fluid bag  152  of the invention. The infusion pump has compartment  154  for receiving the fluid bag. The compartment has a hinged door  156  which is shown in its open position in FIG. 17A. The hinged door includes a release latch  158 . At one end of the chamber are a roll-up roller  160  and an opposing roller  162 . The roll-up roller travels at a constant speed in conjunction with the opposing roller so that the rollers travel the length of the bag to sequentially compress the bag and sequentially force the fluid from the chambers toward the exit ports. The roll-up roller can be driven by a variety of means, e.g., a spring drive mechanism housed in the enlarged side portion  163  of the pump which also functions as a hand grip. The hand grip is preferably covered with a “soft feel” material. The fluid bag shown in FIG. 17A has three exit ports  164 ,  166  and  168  that are coupled to an injection molded manifold  170  that functions as fill ports for the chambers and includes check valves. The solutions from the separate chambers are coupled to an exit tube  172 .  
         [0144]    The infusion pump  150  may have status indicators  174  for indicating the progress of the infusion. The pump may be an entirely mechanical device that may be operated by a spring mechanism. The pump may have a curved back surface  176  for ergonomically fitting again a patient&#39;s body.  
         [0145]    FIGS.  18 A- 18 C show another infusion pump  177  having an installed fluid bag for the administering the SASH infusion procedure. This embodiment of the pump includes electronic control circuits and mechanisms for programmable control of the roller mechanism. Programmable control allows the roller mechanism to operate at a variable rate. Further, the roller mechanism may be stopped between chambers for a desired time interval.  
         [0146]    [0146]FIG. 19A shows a control panel  178  for one embodiment of the infusion pump  177  of FIGS.  18 A- 18 B. The pump&#39;s control panel has three buttons and four lights. The first button  180  is a start or run button for beginning the infusion procedure. The next button  182  is a stop or pause button to interrupt the infusion for a relatively brief pause. The third button  184  is a discontinue dose button for terminating the infusion. The lights indicate the status of an infusion and may be light emitting diodes, incandescent lamps, or the like. After the start or run button has been pressed and the roller is sequentially compressing the bag&#39;s compartments, the running light  186  will be lit. If the pause button is pressed during the infusion procedure, the stopped/pause light  188  will be lit. When the infusion has been completed, the bag empty light  190  will be lit. An additional light  192  indicates whether an occlusion has occurred in the infusion line leading to the patient.  
         [0147]    [0147]FIG. 19B shows a control panel  178  for a second embodiment of the infusion pump  177  of FIGS.  18 A- 18 C. The panel further includes, in addition to the buttons discussed above with respect to FIG. 19A, a clock  192 , a keypad  194 , and three dose select buttons  196 . The keypad may be used to enter a prescribed infusion therapy. The dosage buttons may be used to select various dose rates or administration times for a given bag (or times for given chambers within a bag) and corresponding drug therapy.  
         [0148]    Another embodiment of the infusion pump mechanism for applying pressure sequentially across a bag  20  of the invention is shown in FIG. 20. The bag rests on a relatively rigid surface  200 . A pressurized bladder  202  is separated from the bag by a movable belt  204 . The bladder is sequentially released by the belt, thus applying sequential pressure across the bag. The belt accordingly replaces, for example, the function of the roller in the infusion pump of FIGS. 17A and 17B. The speed at which the belt releases the bladder controls the pumping speed of the infusion pump.  
         [0149]    Yet another embodiment of the infusion pump pressure mechanism is shown in FIG. 21. Pressure is applied to the bag  20  by a series of inflatable bladders  206 . The bladders are inflated sequentially so that the series of bladders perform the same function as the rollers shown in FIGS. 17A and 17B. A timer or a pressure sensor feedback mechanism (not shown) initiates the inflation of each subsequent bladder of the series of the desired time.  
         [0150]    Another embodiment of the infusion pump pressure mechanism is shown in FIG. 22. The mechanism includes a series of bladders  206  that press a flexible pad  208  against the bag. The bladders are inflated sequentially and the flexible pad operates to smooth out pressure variations caused by the inflation of each individual bladder.  
         [0151]    An additional embodiment of the infusion pump, shown in FIG. 23, has a single bladder  210  that is pressurized after the bag is installed in the pump. The pump further includes valves configured to press against the respective passages of the chambers. The flow rate and sequence of fluids flowing from the chambers may be controlled by the valves, the applied pressure, and restrictive orifices to actively control the infusion process.  
         [0152]    [0152]FIG. 24 shows a pump cartridge  410  inside one embodiment of a pump  400 . In this embodiment of the invention there is only one roller  402  that is held and guided by two slots  404  (only one slot is shown) to roll over the cartridge  410 . The roller is biased by a spring  406  to roll over the cartridge  410  and expel the fluids via exit port  408 . This embodiment can also use a motor and worm gear to drive the roller  402  over the cartridge  410  to dispense the fluid in the cartridge. The force applied to the roller by the motor and worm gear is controlled to produce the desired Q for any given R, L and chamber geometry. FIG. 24 shows the fluid chamber  409  having a top curved wall  407  and a relatively flat bottom wall  411 . However, depending on the materials used, both the top wall  407  and the bottom wall  411  can be curved, thus making a relatively symmetrical fluid chamber.  
         [0153]    [0153]FIG. 25 shows one aspect of the invention in which a cartridge  414  with four chambers is placed in a vertically oriented rectangular hopper  412 . as the cartridge  414 ′ is fed through the rollers  418  and  420 , fluid is squeezed out of the cartridge  414  through line  408 . The rollers are driven by motor  428  via shaft  426  to clutch  424  which drives the shaft  422  that drives the rollers  418  and  420 . The clutch  424  is used to limit the maximum amount of force that can be applied to the rollers. The roller  418  is shown with optional tractor feed teeth  416  that can engage corresponding holes in the cartridge  414  for the purpose of applying a consistent force to the cartridge and preventing slippage of the cartridge when engaged by the rollers.  
         [0154]    While the foregoing has been with reference to specific embodiments of the invention, it will be appreciated by those skilled in the art that these are illustrations only and that changes in these embodiments can be made without departing from the principles of the invention, the scope of which is defined by the appended claims.