Abstract:
A containment and intravenous delivery bag device for supplying a patient with mixed chemical component nutrients includes a first pouch and a second pouch that are separated by a tube passageway. Using standard intravenous delivery bag sizes and manufacturing techniques, the tube passageway is blocked by either a clamp or a frangible valve fitted within the tube. The clamp or valve is opened, allowing fluids with the pouches to mix. The mixed liquid may then be delivered to the patient.

Description:
This application is a continuation-in-part of application Ser. No. 08/954,437 filed Oct. 20, 1997, now issued as U.S. Pat. No. 6,071,262, for “System for Infusing Intravenous Nutrition Solutions.” 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     A two-chambered receptacle for intravenous use is disclosed. Specifically, the subject receptacle comprises two pre-connected pouches linked by a connection tube that can be controlled to prevent mixing of the pouch components. More specifically, the two-chambered receptacle usually contains the components of a Total Parenteral Nutrition (TPN) solution. Usually, one pouch contains readily inactivated compounds such as lipids and the other pouch contains the remainder of the TPN solution. 
     2. Description of the Background Art 
     Complex solutions are often needed by patients undergoing varied types of medical treatments. Unfortunately, the components within the complex solutions often interact with one another when mixed. Thus, for reasons of chemical reactivity, neutralization, inactivation, precipitation, unwanted side-reactions, and the like, compartmented chemical, drug, and nutrient delivery containers need to exist and have existed for years. With these compartmented delivery systems, the components of the complex mixture are held in separate compartments, and the components are mixed immediately before usage by a patient. 
     Total Parenteral Nutrition (TPN) is one area in which complex mixtures of components are required. Typical components for a TPN solution are: fluids; carbohydrates; electrolytes; proteins; lipids; vitamins; and trace minerals. For diverse reasons, some patients can not be fed orally and require intravenous (IV) feeding. TPN supplies the nutrients needed by a particular patient. Usually, the nutrients are mixed by a pharmacy in a sterile IV container. Generally, the lipids should be separated from the bulk of the TPN solution until just prior to patient use. The subject invention permits such separation in an efficient, cost-effective, reliable, and easily-utilized form. 
     Various type of complex and costly medical solution bags have been presented in the previous literature. Most have numerous components that increase the expense of the product and augment the possibility of improper operation or wasted time in verifying that proper connections have been fashioned. One specific example of an existing two-chamber bag is one supplied by Baxter Laboratories (the All-In-One™). This bag is very similar to the one described in U.S. Pat. No. 4,458,811 referenced below, in that it contains two immediately adjacent chambers that are mixed by pulling away a “pull-tab” that separates the two chambers. Basically, a single bag is used with a rubber separator. Unfortunately, the type of arrangement with two immediately-related chambers has been found to leak during mixing and shipping (the rubber separator fails), a difficulty not found with the subject invention. 
     More specifically, U.S. Pat. No. 3,788,374 relates to a parenteral solution bag. Openings protrude from the perimeter of the bag for entering and exiting parenteral solution. A fused tearing tab is included with a protective closure for hermetically enclosing the protruding portion. 
     U.S. Pat. No. 4,198,972 discloses a blood and blood component storage bag having at least two hermetically-enclosed inlets at the top. Included is a burstable seal below at least one of the inlets. 
     Disclosed in U.S. Pat. No. 4,211,019 is an accommodative foot bed that has a resin storage bag that comprises two separated chambers with a jointly breakable connection. Upon breaking the connection, the resin components mix and enter a mixing chamber, thereby activating the resin for setting. 
     A platelet freezing bag is related in U.S. Pat. No. 4,365,629. Pull-apart seals protect as least two needle ports mounted in a flexible bag. An exit port is located near a push-apart seal formed in the body of the bag. 
     Described in U.S. Pat. No. 4,458,811 is a compartmented flexible solution container that has an elongated frangible member that separates the compartments. Breaking the elongated frangible member permits a user to mix the components kept within the compartments. 
     Presented in U.S. Pat. No. 4,507,114 is a multiple chamber container having a leak detection compartment. A leak detection pathway normally has no liquid within it, but upon leakage at the connection point between two compartments liquid appears in this leak detection pathway and a visual or similar detection system activated. 
     U.S. Pat. No. 4,608,043 describes an IV fluid storage and mixing system that has a two-compartment construction in which the two compartments are connected upon the application of force via a weakened section in a common wall. Once the weakened section ruptures, the solutions in each compartment encounter one another and mix when the bag is manipulated in a user&#39;s hand. 
     U.S. Pat. No. 4,661,100 discloses a urinary receptacle having a central bag for holding urine with least one internal container within the central bag that may be opened and the contents of the internal container mixed with the contents of the central bag. 
     Lastly, revealed in U.S. Pat. No. 5,394,907 is a device and method for dosing a liquid product. An enclosed bag has means for pinching off one or more compartments and means for introducing differing solutions into these pinched-off compartments. Upon removal of the pinching means, the solutions mix. 
     Each of the prior art inventions attempt to solve the problem of producing multi-chambered receptacles in ways that are not entirely satisfactory for IV use. For example, the prior art inventions often experience sealing problems that may cause or result in leaking between compartments. Other methods that incorporate mechanical separation do so in ways that are not entirely compatible with the size of IV equipment. In summary, there is a need in the art for improved multi-chambered IV receptacles. 
     The foregoing patents reflect the state of the art of which the applicant is aware, and are tendered with the view toward discharging applicant&#39;s acknowledged duty of candor in disclosing information which may be pertinent in the examination of this application. It is respectfully submitted, however, that none of these patents teach or render obvious, singly or when considered in combination, applicant&#39;s claimed invention. 
     SUMMARY OF THE INVENTION 
     An advantage of the present invention is to provide a liquid nutrient storage and delivery system that is leak-resistant and not subject to premature mixing of liquids contained within the system. 
     A further advantage of the present invention is to provide a method of utilizing a liquid nutrient storage and delivery system in a manner that minimizes leakage or inadvertent mixing of contained liquids. 
     Another advantage of the present invention is to disclose a liquid nutrient storage and delivery system that comprises relatively thin pouches that are approximately the same width as standard intravenous bags. 
     Yet another advantage of the present invention is to disclose a liquid nutrient storage and delivery system that contains two liquids that are stored separately from one another in the system prior to patient use, and allows for combining and mixing of the liquids prior to use. 
     An advantage of one embodiment of the present invention is to supply a liquid nutrient storage and delivery system that is leak-resistant and contains a connection tube that has a valve that permits mixing of two liquids only upon an irreversible breaking of a frangible member of the valve. As a further advantage, a liquid nutrient storage and delivery system is furnished that has two separate pouches connected by a valve-containing tube, thereby preventing leakage or mixing of liquids held within the pouches. 
     An advantage of a second embodiment of the present invention is to supply a liquid nutrient storage and delivery system that is leak-resistant and contains a connection tube with a clamp that permits mixing of the two liquids upon release of the clamp. 
     Yet a further advantage of the present invention is to provide a method of utilizing a liquid nutrient storage and delivery system in a manner that minimizes leakage or inadvertent mixing of contained liquids. 
     Disclosed is a containment and intravenous delivery system for supplying a patient with mixed chemical component nutrients. Comprising the subject invention is a first pouch usually having top, bottom, and two opposing side borders. More specifically, the first pouch additionally comprises a first port mounted in the first pouch bottom border and a second port mounted in the first pouch bottom border. The second port is for filling the first pouch with a first liquid. 
     Further included in the subject invention is a second pouch with about a standard intravenous single bag width. Like the first pouch, the second pouch has top, bottom, and two opposing side borders. The second pouch has a third port mounted proximate the second pouch top border, a fourth port mounted proximate the second pouch bottom border, a fifth port mounted proximate the second pouch bottom border, and a sixth port mounted proximate the second pouch bottom border. 
     In a first embodiment, a tube connects the first port and the third port and has a valve mounted in the tube. The valve comprises a body, a frangible element associated with the body, and a stop member. When the frangible element is broken, a first liquid within the first pouch may enter the second pouch through the tube and mix with a second liquid. The stop member prevents the frangible element from exiting the tube yet allows the first liquid to enter the second pouch through the tube. 
     Generally, the first embodiment incorporates additional means for releasably blocking the passageway at a position between the valve and the second pouch. Usually, the releasable blocking means comprises a ratchet, slide, on-off or some other type of clamp that fits about the tube and may be positioned between open and closed to allow liquid passage or to block liquid passage, respectively. 
     In a second embodiment, a tube connects the first port and the third port and has a blocking or clamping mechanism surrounding the tube. The clamping mechanism comprises a ratchet, slide, on-off or some other type of clamp to control the flow of material between pouches. Mixing of the first pouch contents in the second pouch occurs after the release of the clamping mechanism. Subsequent to clamp opening, the contents are mixed in the first pouch, and the clamp may be re-closed to keep the contents from flowing back into the second pouch. 
     One advantage of the subject TPN system over existing technologies is a much more effective separation of the two fluid components from one another, which minimizes leakage possibilities. Another advantage of the subject system is that the receptacle or pouches is much thinner than the existing bags (like the one found in the All-In-One™ system and equivalent structures). Thinness is important for the patient who must fit the bag into a backpack which is not designed for the wider-type bags. The wider design (like the one found in the All-In-One™ system) is to accommodate an adequate volume for the lipid chamber. The subject receptacle has a standard transfusion single bag width which patients, patient-producers, and patient-products have been using for several decades. Thus, the width of the subject system receptacle permits usage of standard-sized associated items. Additionally, some patients have been found to “fold” their wider bag systems (not the subject receptacle) to fit into their carrying cases. This can lead to a portion of the solution leaking into folds and crevices not readily accessible for delivery to the patient, and compromise the TPN therapy. 
     Other objects, advantages, and novel features of the present invention will become apparent from the detailed description that follows, when considered in conjunction with the associated drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a planar view of a first embodiment of the subject invention. 
     FIG. 2A is a cross-sectional elevational view of the “break-away” or frangible valve and associated tubing of the first embodiment of the subject invention showing no liquid flow within the tubing. 
     FIG. 2B is a cross-sectional elevational view of the “break-away” or frangible valve and associated tubing of the first embodiment of the subject invention showing free passage of a liquid through the tubing after the frangible valve is broken. 
     FIG. 3 is a planar view of a second embodiment of the subject invention. 
     FIG. 4A is a side view of the ratchet clamp comprising the clamp assembly of the second embodiment. The clamp is shown in a released (solid) and clamped (dashed) position. 
     FIG. 4B is a perspective view of the slide clamp comprising the clamp assembly of the second embodiment. Tubes are shown in a released (solid) and clamped (dashed) position. 
     FIG. 4C is a view of the on-off clamp comprising the clamp assembly of the second embodiment. FIG.  4 C′ is a top view and 
     FIG.  4 C″ is a side cross-sectional view, with the clamp shown in a released (solid) and clamped (dashed) position. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to FIGS. 1,  2 A, and  2 B, there is shown a first embodiment of a two-chambered nutrition bag or receptacle system  5 . Comprising the subject system is a first or larger volume pouch or bag  10  and a second or smaller volume pouch or bag  15 . Commonly, the larger pouch  10  holds between about one and about four liters, more generally about 2.5 liters. The smaller pouch  15  usually contains between about 50 mL and about one liter, more commonly about 300 mL. Each pouch  10  and  15  is fabricated from suitable natural and synthetic polymers, frequently ethylene vinyl acetate or equivalent material. 
     Although other equivalent configurations are within the realm of this disclosure, the larger pouch  10  generally comprises opposing polymeric sheets that are fused or adhered to one another to form the pouch  10 . Preferably, the pouch  10  has top  20 , bottom  25 , and two opposing side borders  30  and  35 . Ports are formed in the pouch  10  by standard means. Usually for the larger pouch  10 , a port  40  is positioned proximate the top border  20  and is utilized in a liquid connection with the smaller pouch  15 . Usually in the bottom border  25  of the larger pouch  10  is placed a fill port  45  used to fill the pouch  10  with the selected liquid nutrients or chemicals. A tube  46  connects to the fill port  45  and has associated with it a fill tip  47  and cover  48 . Also, an injection port  50  is usually located in the bottom border  25 , but other border locations are possible as would be with the fill port  45 . The injection port  50  is employed to introduce additional components (chemicals, solutions, and the like) into the bulk solution within the pouch  10 . Further, usually in the bottom border  25  is placed the patient port  55  that may be accessed by standard means for delivery of the contained liquid to the patient. Apertures  60  are formed in the pouch  10  for hanging the pouch in various desired positions. 
     As above with the larger pouch  10 , although other equivalent configurations are within the realm of this disclosure, the smaller pouch  15  generally comprises opposing polymeric sheets that are fused or adhered to one another to form the pouch  15 . Preferably, the pouch  15  has top  65 , bottom  70 , and two opposing side borders  75  and  80 . Generally, a connection port  85  is placed in the bottom border  70  of the smaller pouch  15 , as is a fill port  90 . The fill port  90 , like the fill port  45  for the larger pouch, is usually fitted with a tube  95 , fill tip  100 , and cover  105 . 
     Connecting the two pouches  10  and  15  is a passage or tube  110  containing a valve  115  (see FIGS.  2 A and  2 B). Commonly, the tube  110  is fabricated from non-reactive natural or synthetic polymers such as TYGON™ tubing and the like. Although other frangible valve designs are within the realm of this invention, usually the valve  115  has a frangible element  120  and a base member  125 . Without breaking the frangible element  120 , no liquid L can flow (F in FIG. 2B) past the valve  115  which prevents leaks (see FIG.  2 A). When the frangible element  120  is broken apart from the base member  125 , liquid L may pass through the valve  115  and travel between the small pouch  15  and the larger pouch  10  (see FIG.  2 B and the flow arrow associated with notation F). The frangible element  120  generally separates from the base member  125  and is prevented from migrating in the tube  110  by a stop  130  fitted within the tube  110 . Liquid L is able to flow F through the stop  130  and the stop only inhibits the motion of the frangible element  120 . 
     Usually, the tube  110  is fitted with a releasable blocking means such as a ratchet clamp  135 . This clamp  135  serves as a means for preventing flow back into the smaller pouch  15  after mixing and as a secondary means for preventing leakage between the two pouches  10  and  15  before a desired mixing. 
     Often the subject system is used by placing lipid in the smaller pouch  15  via fill spike  100  and the TPN solution in the larger pouch  10  via fill spike  47 . Frequently, the fill ports  45  and  90  are sealed and the tubes  46  and  95  are removed before the subject system is shipped to a user. The breakaway valve  115  and the ratchet clamp  135  ensure that the two solutions do not mix during shipping and storage. 
     Just prior to hookup by a selected patient, the patient opens the ratchet clamp  130  and breaks the frangible member  120  from the base member  125  by bending the tubing  110  at the valve  115  until the lipids can freely flow into the larger pouch  10 . Generally, the ratchet clamp  135  is closed after the lipids are mixed into the larger pouch  10  to prevent back-flow of the mixed liquid into the smaller pouch  15  and the patient can then access the final solution via the patient port  55 . 
     Referring now to FIGS.  3  and  4 A-C, there is shown a second embodiment of a two-chambered nutrition bag or receptacle system  5 . The configuration and limitations of each of pouches  10  and  15  are the same as those described for the first embodiment, including materials and construction. In the second embodiment, tube  110  is fitted with clamp  140  to prevent the flow of liquid between pouches  10  and  15  in place of valve  115  of the first embodiment (see FIG.  1 ). Clamp  140  ensures that the two solutions do not mix during shipping and storage, and also serves as the means for preventing flow back into the smaller pouch  15  after mixing. The function of clamp  140  is to isolate the contents of pouches  10  and  15  before mixing of the liquids in pouch  10 , and keeping the mixed liquids from flowing back into pouch  15  after mixing. Examples of three of the many type of clamps that can perform this function are the ratchet clamp, slide clamp and on-off clamp, as shown in FIGS. 4A-C respectively. Clamped and unclamped positions are shown for each of the clamps on FIG. 4 using dashed and solid lines, respectively. In a first clamp embodiment, FIG. 4A shows clamp  140  as a ratchet clamp in side view, with both the unclamped (solid) and clamped (dashed) configurations illustrated. A second clamp embodiment is shown in FIG. 4B, where clamp  140  is a slide clamp in perspective view. Tube  110  is shown relative to the clamp in an unclamped position (solid) and clamped position (dashed). A third clamp embodiment is shown in FIG.  4 C. FIG.  4 C′ is a top view and FIG.  4 C″ is a side cross-sectional view of an on-off clamp  140 . The clamp is shown in an unclamped (solid) and clamped (dashed) configuration. Each of the three clamp embodiments can reversibly stop and start the flow through tube  110 . The description of clamp types and clamp operation described and shown herein is not meant to limit the scope of this invention. In particular, there are many other clamp types and configurations known to those in the art, in addition to the embodiments described here, that could perform the functions of clamp  140 , and should be considered to be equivalent. 
     One of the many possible modes of operation of the second embodiment is illustrated in the previously-considered example of placing lipid in the smaller pouch  15  via fill spike  100  and the TPN solution in the larger pouch  10  via fill spike  47 . Frequently, the fill ports  45  and  90  are sealed and the tubes  46  and  95  are removed before the subject system is shipped to a user. The clamp  140  ensures that the two solutions do not mix during shipping and storage. 
     Just prior to hookup by a selected patient, the patient opens clamp  140 , allowing the lipids to freely flow into the larger pouch  10 . Generally, the clamp  140  is closed after the lipids are mixed into the larger pouch  10  to prevent back-flow of the mixed liquid into the smaller pouch  15  and the patient can then access the final solution via the patient port  55 . 
     The invention has now been explained with reference to specific embodiments. Other embodiments will be suggested to those of ordinary skill in the appropriate art upon review of the present specification. 
     Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.