Abstract:
A method for selectively dispensing fluid components through a bypass, the bypass having a fluid passage with an inlet, a first outlet that is unsealed, and a second outlet that is sealed, includes the steps of inserting a tubing line into the second outlet to unseal the second outlet, sealing the first outlet to prevent flow of fluid through the first outlet, and delivering a first fluid component into the inlet of the bypass and through the second outlet.

Description:
RELATED APPLICATION 
   This divisional application is being filed in accordance with 35 U.S.C. §121 and claims priority to U.S. patent application Ser. No. 10/942,529, filed Sep. 16, 2004 now U.S. Pat. No. 7,204,277, the entire contents of which is incorporated by reference herein. 

   FIELD OF THE INVENTION 
   The present invention relates generally to compounder systems, and more particularly, to a compounder system having a bypass for transferring different types of solutions into separated chambers of a receiving receptacle. 
   BACKGROUND OF THE INVENTION 
   Hyperalimentation therapy is the intravenous feeding of nutrients to patients. A typical solution would include a protein-carbohydrate mixture. It is used primarily to meet the patient&#39;s protein and caloric requirements that are unable to be satisfied by oral feeding. The protein may be in the form of free-amino acids or protein hydrolysate and the carbohydrate commonly is dextrose. In addition to the protein and carbohydrate, vitamins (water-soluble and fat-soluble) and electrolytes also can be supplied in this therapy. 
   Each of these parenteral ingredients and the combination thereof are particularly susceptible to the growth of deleterious organisms and it is desirable that they be administered to the patient in a sterile condition. In addition, the solutions are tailor made to specific patient requirements under the direction of a physician. Thus, because these protein and carbohydrate solutions must be combined close, but prior, to their time of use, their compounding must be performed under sterile conditions to avoid organism growth. 
   As a part of this compounding, the solutions that are to be administered intravenously are transferred into a total parental nutrition bag (commonly referred to as a TPN bag). Such bags are designed for home use or use in a hospital or care facility. Once filled they can be stored for a limited period of time in a standard refrigerator. The bags are filled with the solutions by a pharmacist either by gravity or by a device known as a high speed bulk compounder. Such compounders typically are capable of supplying solutions from up to nine different source bags (and possibly more) or containers to a receiving product bag at relatively high flow rates. 
   The source containers may be hung from a framework of the compounder while the receiving bag is hung from a load cell that measures the weight of the receiving bag. A pump set consisting of a number of pump legs (for example, nine or more such legs) or flow paths is designed to be used with the compounder. Each of the pump legs includes flexible tubing and terminates on one end with a piercing administration spike or similar connector that is used to connect the leg of the pump set to one of the source containers. The other end of each leg is coupled to one of the inlet ports of a common manifold equipped with an exit port that is adapted to be coupled to a fill tubing connected to the receiving TPN product bag. 
   In those instances where a high-speed compounder is used, each leg of the pump set is associated with a different peristaltic pump or pump station of the compounder. A microprocessor in the compounder controls each of the peristaltic pumps or pump stations to thereby control the amount of solution being supplied from each source container through the particular pump leg and the manifold to the receiving product bag. The amount of solution being supplied from each source container is in part determined by information being supplied to the microprocessor of the weight being measured at selected times by the load cell from which the receiving bag is suspended. The peristaltic pumps draw solutions from each of the source containers sequentially under the control of the microprocessor and the solutions flow through the common manifold and the fill tubing into the receiving product bag. 
   A problem arises when one of the fluids to be introduced into the product bag is a lipid solution. Lipid solutions are essentially fat emulsions and typically are placed into a separate compartment within the product bag which is isolated from the remaining mixture until immediately before (or very soon before) the solution is administered to a patient. This isolation is necessary because the lipid solution, if mixed with the other ingredients ahead of time, clouds the overall solution mixture and renders it unusable. This phenomena is known in the art as “hazing.” Because of the undesirability of mixing lipids with the other solutions prior to the time of administration, a problem has existed in the prior art where a residual amount of the lipid solution is allowed to remain in a common volume of the manifold after a lipid solution is pumped through but before the next non-lipid solution is pumped through. When the subsequent solution is pumped through, the residual lipid solution is carried into the product bag and hazing results. 
   One solution has involved the use of a chambered product bag. By pumping the lipids into a separate chamber of the product bag, the lipids will not mix and “haze” the solution. Immediately before the solution is used, the separated chamber with the lipids is allowed to mix with the remaining solution to form the product solution. To fill the chambered bag using conventional compounders, one line of the compounder must be devoted specifically for lipids and be attached directly to the separated chamber of the product bag. By using the compounder in this manner, however, one line is not used if the overall solution does not require a lipid component. 
   SUMMARY OF THE INVENTION 
   The present invention is directed to a tube set for dispensing components into a product bag. The tube set comprises a plurality of tubing lines, a manifold, and a bypass. The manifold has a plurality of inlets, each inlet adapted for connection to a respective tubing line. The manifold also has an outlet connectable to a first feed tube of a product bag. The bypass is associated with at least one of the plurality of tubing lines. The bypass has a bypass inlet connectable to the tubing line associated with the bypass. The bypass also has at least two outlets. A first outlet is connected to a tube line in fluid communication with an inlet of the manifold and a second outlet is removably connectable to a second feed line in fluid communication with the product bag. 
   According to another embodiment, the present invention is directed to a bypass for a tube set. The tube set includes a manifold and a plurality of tubing lines for dispensing fluid components into a product bag. The bypass comprises an inlet fluid passage adapted for connection to a tubing line of the tube set, an outlet adapted to receive a tubing line in fluid communication with the product bag, and a bypass fluid passage adapted for connection to a tubing line in fluid communication with the manifold. The bypass is configured such that fluid enters the bypass inlet fluid passage and exits through the outlet only when the outlet is connected to a tubing line in direct fluid communication with the product bag. 
   An exemplary method of the present invention is a method for selectively dispensing fluid components into a product bag attached to a tube set of a bulk compounder. The bulk compounder includes a product bag attached to a tube set having a plurality of tube lines, a manifold, and a bypass having a fluid passage with an inlet and at least two outlets. The method includes providing liquid components to be dispensed into the product bag with one of the liquid components to be maintained separately from the other liquid components, inserting a tube line in fluid communication with the product bag into the bypass first outlet, blocking the bypass second outlet in fluid communication to the manifold, and dispensing the fluid component to be maintained separate from the other liquid components through the bypass and into the product bag, independent of the manifold. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  illustrates an exemplary bulk compouder having a bypass according to an embodiment of the invention; 
       FIG. 2  illustrates an exemplary bypass according to another exemplary embodiment of the present invention; and 
       FIG. 3  is an enlarged view of an exemplary bypass according to the present invention. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   Although the invention is illustrated and described herein with reference to specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention. 
   Referring to the Figures where like numerals represent like features,  FIG. 1  shows a pharmaceutical compounding system  10 . System  10  can be used for mixing or compounding two or more selected liquids and/or drugs intended to be administered to a human being or an animal. In use, system  10  serves to transfer two or more of individual prescribed liquids and/or drugs from multiple source containers (e.g., individual vials, bottles, syringes, or bags) into a single collecting container (e.g., a bottle, syringe, or bag), so that the mix of liquids and/or drugs can be administered (e.g., intravenously) to an individual in need. 
   As one example, due to injury, disease, or trauma, a patient may need to receive all or some of his or her nutritional requirements intravenously. In this situation, the patient will typically receive a basic solution containing a mixture of amino acids, dextrose, and fat emulsions, which provide a major portion of the patient&#39;s nutritional needs, which is called total parenteral nutrition, or, in shorthand, TPN. In this arrangement, a physician will prescribe a mixture of amino acids, dextrose, and fat emulsions to be administered, as well as the frequency of administration. To maintain a patient for an extended period of time on TPN, smaller volumes of additional additives, such as vitamins, minerals, electrolytes, etc., are also prescribed for inclusion in the mix. Using system  10 , under the supervision of a pharmacist, the prescription order is entered and individual doses of the prescribed liquids, drugs, and/or additives are accordingly transferred from separate individual source containers for mixing in a single container for administration to the individual. 
   There are other environments where system  10  is well suited for use. For example, in the medical field, system  10  can be used to compound liquids and/or drugs in support of chemotherapy, cardioplegia, therapies involving the administration of antibiotics and/or blood products therapies, and in biotechnology processing, including diagnostic solution preparation and solution preparation for cellular and molecular process development. Furthermore, system  10  can be used to compound liquids outside the medical field. 
   Tube set  15  is a part of system  10 . Tube set  15  includes lengths of transfer tubing line  20 , which are joined at one end to a common manifold  45 . At the opposite ends of the transfer tubing  15  are spikes or releasable couplings  100 . Couplings  100  can be inserted in conventional fashion through a diaphragm carried by the associated source solution container (not shown), which allows flow communication between the source solution container and the respective transfer tubing line  20 . From manifold  45 , a first feed line  50  is coupled to a product bag  80 . As shown in the embodiment of  FIG. 1 , product bag  80  has two compartments, a lower compartment  70  in connection with first line  50 , and an upper compartment  65  in connection with a second feed line  60 . Transfer tubing lines  20 , first feed line  50 , and second feed line  60  can be made from flexible, medical grade plastic material, such as polyvinyl chloride plasticized with di-2-ethylhexyl-phthalate. Likewise, product bag  80  can be made from a flexible, medical grade plastic, semi-rigid plastic or glass. 
     FIG. 1  illustrates system  10  having a bypass  23  for directing liquids through manifold  45  or directly to upper compartment  65  of product bag  80  by way of second feed line  60 . As discussed above, once the lipid solutions are mixed with other types of solutions, the shelf life for the mixed solution (i.e., the amount of time before the solution needs to be used) is relatively short. Thus, there is a need to prepare dual-chambered bags having lipid solution dispensed into one compartment of the dual chambered product bag without wasting a tubing line or without the added need for a complete separate transfer tube line. 
     FIG. 2  illustrates an embodiment of bypass  23  of system  10 . Bypass  23  has inlet  25  of inlet fluid passage  220 , which can be adapted for fluid communication with transfer tubing line  20  (not shown in  FIG. 2 ). Connected to inlet fluid passage  220  is bypass fluid passage  200  forming a three-way junction at outlet  30 . Bypass fluid passage  200  also has outlet  35  for connection with a tubing line (not shown in  FIG. 2 ) to be in fluid communication with manifold  45 . Alternatively, bypass  23  can be described as having an inlet connectable to at least one tubing line  20  and two outlets, where one of the outlets is connectable to a tube in fluid communication with an inlet of manifold  45 . The second outlet is removably connectable to second feed line  60  of product bag  80 . 
   Also shown in  FIG. 2  is flip-top cap  33  which is adapted to cover outlet  30  when second feed line  60  is not connected to outlet  30 . Disposed within outlet  30  is a resealable membrane  210  that is self-sealable when punctured, such as a diaphragm valve. Membrane  210  allows a male portion of first feed line  60  to be inserted into outlet  30 . Membrane  210  prevents fluids traveling through bypass  23  from escaping. Although membrane  210  is described as a membrane, it can be a washer or other suitable device that would prevent fluid from escaping the connection between second feed line  60  and outlet  30  as would be understood by one skilled in the art. 
     FIG. 3  is an enlarged and partially cut-away view of inlet fluid passage  220  and bypass fluid passage  200  at outlet  30  with second feed line  60  inserted into outlet  30 . According to this embodiment, second feed line  60  has a male connector at the end which meets bypass  23  at bypass outlet  30 , which is a female end. In the embodiment shown in  FIG. 3 , the male end of second feed line  60  is a hollow penetrating probe  230  that pierces membrane  210 . As probe  230  is fully inserted into outlet  30 , probe  230  seals bypass fluid passage  200  from inlet fluid passage  220 . By sealing or blocking bypass fluid passage  200 , fluids flow into inlet fluid passage  220  and into second feed line  60 . The other end of second feed line  60  is adapted for connection to upper compartment  65  of compartmentalized product bag  80  as shown in  FIG. 1 . Likewise, when probe  230  of second feed line  60  is removed from outlet  30 , resealable membrane  210  closes and fluid flows from inlet fluid passage  220  through to bypass fluid passage  200 . Bypass fluid passage  200  is in fluid communication with manifold  45  by way of a bypass to manifold tubing line  40  (shown in  FIG. 1 ). 
   As shown in the embodiment of  FIG. 3 , bypass  23  is shaped similar to a “y”. Bypass  23  is a three-way connector and may also be shaped like a “T”. Between inlet fluid passage  220  and bypass fluid passage  200  is the angle θ. Angle θ can be greater than 0° to less than 180°, preferable less than 90°. According to the embodiment shown in  FIG. 3 , angle θ is 45°. 
   Referring again to  FIG. 1 , fluid components from tube set  15  connected to individual fluid bottles (not shown) through couplings  100 , deliver liquids that flow to manifold  45  and through first feed line  50  into product bag  80 . When a composition of liquids calls for a component that must be maintained separate until just before use, one tube line  20  from tube set  15  is connected to inlet  25  of bypass  23 . A second feed line  60  is connected to outlet  30  of bypass  23 . Second feed line  60  is in direct fluid communication with upper compartment  65  of product bag  80 . In this configuration, the liquid to be maintained separate will flow through tube line  20  connected to bypass  23  and exit outlet  30  connected to second feed line  60  as shown by line A. In this configuration, the fluid (e.g. a lipid solution) will not pass through manifold  45  and prematurely mix with the other liquid components, but rather will directly flow to upper chamber  65  of product bag  80  independent of manifold  45 . 
   When a lipid solution is not used in the formulation, i.e., when components of the liquid need not remain separate from the other components, second feed line  60  may be removed from bypass  23 . Thus, the liquid in the tube line connected to bypass inlet  25  will flow to bypass  23  and will exit via bypass fluid passage  200 , which is connected via tubing  40  to manifold  45 . The fluid flow direction is shown by line B in  FIG. 1 . Once the fluid enters manifold  45 , it exits manifold  45  by way of first feed line  50 , common to the other tubing lines  20 , and flows into lower compartment  70  of product bag  80 . 
   According to an embodiment of the present invention, tube set  15  connected to manifold  45  and bypass  23  can be fabricated independently and joined together to form a single device made up of these individual components. Preferably, these components can be ultrasonically welded to their respective mate. The means of joining the components are discussed in detail below. The primary advantage to such a construction is ease of manufacture. 
   Bypass  23  could be made from any of a number of suitable materials, including plastics, such as polycarbonates, that are suitable to handle the pharmaceutical and food preparations that will be passing therethrough. The suitable materials should also preferably be such that they can be injection molded to form the parts of the device, or the whole device, and one skilled in the art would know such materials. 
   While preferred embodiments of the invention have been shown and described herein, it will be understood that such embodiments are provided by way of example only. Numerous variations, changes and substitutions will occur to those skilled in the art without departing from the spirit of the invention. Accordingly, it is intended that the appended claims cover all such variations as fall within the spirit and scope of the invention.