HK1105617B - By-pass line connector for compounding system - Google Patents

Description

Bypass line connector for mixing system

Technical Field

The present invention relates generally to a mixer system and, more particularly, to a mixer system having a bypass for delivering different types of solutions to individual chambers of a receiving container.

Background

Intravenous nutrient solution therapy is a method of supplying nutrients to a patient intravenously. Conventional solutions include protein-carbohydrate mixtures. It is primarily used to meet the protein and caloric needs that patients cannot meet through oral delivery. The protein may be in the form of free amino acids or protein hydrolysates and the carbohydrate is typically glucose. Vitamins (water soluble or fat soluble) may also be supplied in this therapy in addition to proteins and carbohydrates.

Each of these parenteral components and combinations thereof are particularly susceptible to the growth of harmful organisms and need to be administered to a patient in a sterile condition. In addition, the solutions are tailored to the needs of the particular patient under the direction of the physician. Therefore, because these protein and carbohydrate solutions must be intimately combined, but before they can be used, their mixing must be done in a sterile state to avoid growth of the organism.

As part of this mixing, the solution to be intravenously supplied is delivered into a total parental nutrition bag (commonly referred to as a TPN bag). Such bags are designed for domestic or hospital use or care facilities. Once the bags are filled, they are stored in a standard refrigerator for a limited period of time. The bag is filled with the solution by the pharmacist either by gravity or by known means such as a volumetric mixer (bulk compounder). Such mixers are typically capable of supplying solution to receiving product bags at relatively high flow rates from up to nine different source bags (and possibly more) or containers.

The source container may be suspended from the frame of the mixer and the receiving bag from a load cell for measuring the weight of the receiving bag. A pump set consisting of several pump branches (e.g. nine or more such branches) or flow channels is designed for use with a mixer. Each pump limb comprises a flexible tube and terminates at one end with a piercing administration tip or similar connector for connecting the limb of the pump set to one of the source containers. The other end of each branch is connected to one of the inlets of a common manifold equipped with an outlet for coupling to a fill tube connected to a receiving TPN product bag.

In the case of high-speed mixers, each branch of the pump group is associated with a different peristaltic pump or pump station of the mixer. A microprocessor in the mixer controls each peristaltic pump or pump station to control the amount of solution supplied from each source container through a particular pump branch and manifold into the receiving product bag. The amount of solution supplied from each source container is determined in part by weight information supplied to the microprocessor measured at selected times by a load cell from which the receiving bag is suspended. A peristaltic pump sequentially draws solution from each source container under the control of the microprocessor, the solution flowing through the common manifold and fill tube into the receiving product bag.

A problem arises when one of the fluids to be introduced into the product bag is a lipid solution. The lipid solution is essentially a fat emulsion and is usually placed in a separate compartment within the product bag until just before (or shortly before) the solution is administered to the patient, it is isolated from the rest of the blend. This isolation is necessary because the lipid solution, if mixed with other ingredients prior to use, can cloud the entire solution mixture and render it unusable. This phenomenon is known in the art as "fogging". Because mixing of the lipid with other solutions prior to administration is undesirable, problems exist in the prior art where a residual amount of the lipid solution remains in the common volume of the manifold after the lipid solution is withdrawn but before the next lipid solution is withdrawn. As the next solution is withdrawn, the residual lipid solution is carried into the product bag and eventually aerosolized.

One solution is to use a product bag with a chamber where the lipids do not blend and "atomize" the solution by pumping the lipids into the individual chambers of the product bag. The separate chamber with the lipid is allowed to mix with the rest of the solution to form the product solution just before the solution is used. In order to fill a chambered bag using a conventional mixer, one line of the mixer must be specifically assigned to the lipids and connected directly to a separate chamber of the product bag. However, by using a mixer in this manner, a line is not used if the entire solution does not require a lipid solution.

Disclosure of Invention

The present invention relates to a tube set for dispensing a component into a product bag. The tube set includes a plurality of lines, a manifold, and a bypass. The manifold has a plurality of inlets, each for connection to a respective line. The manifold also has an outlet connectable to a first feed tube of the product bag. The bypass is associated with at least one of the plurality of pipelines. The bypass has a bypass inlet connectable to a line associated with the bypass. The bypass also has at least two outlets. The first outlet is connected to a line communicating with the manifold inlet and the second outlet is removably connected to a second feed line communicating with the product bag.

According to another embodiment, the invention relates to a bypass for a tube set. The tube set includes a manifold and a plurality of lines for dispensing the fluid component to the product bag. The bypass includes an inlet fluid passage for connection to a tubing line of the tubing set, an outlet for receiving a tubing line in fluid communication with the product bag, and a bypass fluid passage for connection to a tubing line in fluid communication with the manifold. The bypass is configured to allow fluid to enter the bypass inlet fluid passageway and exit through the outlet when the outlet is connected to a line in direct fluid communication with the product bag.

An exemplary method of the present invention is a method for selectively dispensing a fluid component into a product bag connected to a tube set of a volumetric mixer. The volumetric mixer includes a product bag connected to a tube set having a plurality of lines, a manifold, and a bypass having a fluid passageway with an inlet and at least two outlets. The method comprises the following steps: providing liquid components to be dispensed into a product bag, wherein one of the liquid components is to be kept separate from the other liquid component; inserting a line in fluid communication with the product bag into the bypass first outlet; blocking a bypass second outlet in fluid communication with the manifold; and dispensing the liquid component to be kept separate from the other liquid components into the product bag by a bypass independently of the manifold.

Drawings

FIG. 1 illustrates an exemplary volumetric mixer with bypass according to one embodiment of the present invention;

FIG. 2 illustrates an exemplary bypass according to another embodiment of the present invention;

FIG. 3 is an enlarged view of an exemplary bypass according to the present invention.

Detailed Description

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, many modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention.

Like reference numerals in the drawings denote like structures. FIG. 1 illustrates a drug mixing system 10. The system 10 may be used to blend or mix two or more selected liquids and/or medicaments to be administered to a human or animal. In use, the system 10 is used to deliver two or more separate ordered liquids and/or medicaments from multiple source containers (e.g., vials, bottles, syringes, or bags) into a single collection container (e.g., a bottle, syringe, or bag) so that a blend of the liquids and/or medicaments can be administered (e.g., intravenously) to an individual as needed.

As an example, a patient may need to receive all or some of his or her nutritional requirements intravenously due to injury, disease, trauma, etc. In such cases, the patient will typically receive a base solution comprising a mixture of amino acids, glucose and a fat emulsion that provides a major portion of the patient's nutritional needs, also known as total parental nutrients, or TPN for short. In this configuration, the physician will prescribe a mixture of amino acids, glucose and fat emulsions to be administered, as well as the frequency of administration. In order to keep the patient using TPN for an extended period of time, small amounts of additional additives, such as vitamins, minerals, electrolytes, etc., may also be included in the mixture. Using system 10, under the supervision of a pharmacist, a prescribed sequence is entered and each individual dose of prescribed liquids, medicaments, and/or additives is delivered from each individual source container accordingly for mixing in a single container for delivery to each individual.

There are other environments in which the system 10 is more suitable for use. For example, in the medical field, the system 10 may be used to mix liquids and/or medicaments in connection with chemotherapy, cardioplegia, therapies involving the administration of antibiotics and/or blood product therapies, and biotechnological processing including diagnostic solution preparation and the preparation of solutions for cellular and molecular processes.

Tube set 15 is part of system 10. Tube set 15 includes multiple lengths of transfer line 20 joined at one end to a common manifold 45. At the opposite end of delivery tube 15 is a pointed or releasable coupling 100. Coupling 100 may be inserted through a membrane carried by an associated source solution container (not shown) in a conventional manner, which allows fluid communication between the source solution container and each transfer line 20. From manifold 45, first feed line 50 is coupled to product bag 80. As shown in the embodiment of FIG. 1, product bag 80 has two compartments, a lower compartment 70 connected to first line 50 and an upper compartment 65 connected to second feed line 60. Transfer line 20, first feed line 50 and second feed line 60 may be made of a flexible medical grade plastic material, such as polyvinyl chloride plasticized with 2 ethylhexyl phthalate. Likewise, product bag 80 may be made of flexible medical grade plastic, semi-rigid plastic, or glass.

Fig. 1 shows system 10 having a bypass 23 for directing liquid through the manifold or directly into upper chamber 65 of product bag 80 through second feed line 60. As noted above, once a liquid solution is blended with other types of solutions, the shelf life of the blended solution (i.e., the amount of time before the solution needs to be used) is relatively short. Thus, it is desirable to prepare a dual-chambered bag that dispenses a lipid solution into one compartment of the dual-chambered product bag without wasting a line and without the additional need for a completely separate delivery line.

Fig. 2 illustrates one embodiment of bypass 23 of system 10. Bypass 23 has an inlet 25 of inlet fluid passageway 220 for fluid communication with transfer line 20 (not shown in FIG. 2). Connected to the inlet fluid passage 220 is a bypass fluid passage 200 that forms a tee junction at the outlet 30. The bypass fluid passage 200 also has an outlet 35 for connection to a line (not shown in fig. 2) to be in fluid communication with the manifold 45. Alternatively, the bypass 23 may be described as having one inlet connectable to at least one of the lines 20 and two outlets, one of which may be connected to a tube in fluid communication with the inlet of the manifold 45. The second outlet is removably connected to second feed line 60 of product bag 80.

Also shown in fig. 2 is a flip top cover 33 for covering outlet 30 when second feed line 60 is not connected to outlet 30. Disposed within the outlet 30 is a releasable membrane 210, such as a diaphragm valve, which is self-sealing when pierced. Membrane 210 allows the projections of second feed line 60 to be inserted into outlet 30. Membrane 210 prevents fluid traveling through bypass 23 from escaping. Although membrane 210 is described as a membrane, it may also be a gasket or other suitable device that prevents fluid from escaping from the connection of second feed line 60 and outlet 30, as will be appreciated by those skilled in the art.

Fig. 3 is an enlarged, partial cross-sectional 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, the second feed line 60 has a male connector at its end where it meets the bypass 23 at the bypass outlet 30, the outlet 30 being a female end. In the embodiment shown in fig. 3, the convex end of second feed line 60 is a hollow penetrating probe 230 that pierces membrane 210. When the probe 230 is fully inserted into the outlet 30, the probe seals the bypass fluid passage 200 from the inlet fluid passage 220. By sealing or plugging the bypass fluid passage 200, fluid flows into the inlet fluid passage 220 and into the second feed line 60. The other end of second feed line 60 is adapted to be connected to upper compartment 65 of a compartmentalized product bag 80, as shown in FIG. 1. Likewise, when probe 230 of second feed line 60 is removed from outlet 30, releasable membrane 210 closes and fluid passes from inlet fluid passageway 220 into bypass fluid passageway 200. The bypass fluid passageway 200 is in fluid communication with the manifold 45 through a bypass of the manifold line 40 (shown in fig. 1).

As shown in the embodiment of fig. 3, the bypass 23 is shaped like a "Y". Bypass 23 is a three-way connection and may also be shaped like a "T". An angle theta is formed between the inlet fluid passage 220 and the bypass fluid passage 200. The angle theta may be greater than 0 degrees and less than 180 degrees, preferably less than 90 degrees. According to the embodiment shown in fig. 3, the angle θ is 45 degrees.

Referring to fig. 1, fluid components from tube set 15, which are connected to individual fluid bottles (not shown) via couplings 100, are transported to manifold 45 and through first feed line 50 into product bag 80. When it is desired that a component in the liquid mixture must be kept separate prior to use, a line 20 from line 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 chamber 65 of product bag 80. In this configuration, the liquid to be kept separate will flow through line 20 connected to bypass 23 and exit through outlet 30 connected to second feed line 60, as shown by line a. In this configuration, the fluid (e.g., lipid solution) will not pass through the manifold 45 and prematurely mix with other liquid components, but will flow directly into the upper chamber 65 of the product bag 80, not associated with the manifold 45.

Second feed line 60 may be removed from bypass 23 when no lipid solution is used in the formulation, i.e., when the liquid component does not need to remain separate from the other components. Thus, liquid in the line connected to the bypass inlet 25 flows into the bypass 23 and out through the bypass fluid passage 200 connected to the manifold 45 via the conduit 40. The fluid flow direction is shown by line B in fig. 1. Once the fluid enters manifold 45, it exits manifold 45 through a first feed line 50 common to the other lines 20 and flows into lower chamber 70 of product bag 80.

According to one embodiment of the invention, the tube set 15 connected to the manifold 45 and the bypass 23 may be manufactured separately and joined together to form a single device made up of these separate elements. Preferably, these elements are ultrasonically welded to their respective mating members. Means for combining the elements are discussed in detail below. The main benefit of this construction is ease of manufacture.

The bypass 23 may be made of any number of suitable materials, including plastics, such as polycarbonate, which are suitable for handling pharmaceutical products and food products to be passed therethrough. The suitable materials should preferably be injection moldable to form parts of the device, or the entire device, and those skilled in the art will be aware of such materials.

While preferred embodiments of the present invention have been shown and described, it will be understood that these embodiments are provided by way of example only. Various changes, modifications and substitutions will occur to those skilled in the art without departing from the spirit of the invention. Accordingly, it is intended by the appended claims to cover all such modifications as fall within the true spirit and scope of the invention.

Claims (15)

1. A tube set for dispensing a component into a product bag, comprising:

a plurality of pipelines;

a manifold having a plurality of inlets, each inlet for connection to a respective line, and an outlet connected to a first feed tube of the product bag;

a bypass associated with at least one of the pipelines, the bypass having:

a bypass inlet connected to at least one of the plurality of lines associated with the bypass; and

at least two outlets, a first outlet connected to a line in fluid communication with the inlet of the manifold, and a second outlet removably connected to a second feed tube of the product bag.

2. The tube set of claim 1, wherein the second feed tube is in fluid communication with the product bag independent of the manifold.

3. The stack of claim 1, wherein the bypass is to direct fluid to only the first outlet when the second feed tube is not connected to the bypass.

4. The stack of claim 1, wherein the bypass is to direct fluid to only the second outlet when the second feed tube is connected to the bypass.

5. The stack of claim 1, characterized in that the bypass is made of plastic.

6. The tubing set of claim 5, wherein the plastic is polycarbonate.

7. The stack of claim 1, further comprising a flip top cover to cover the second outlet when the second outlet is not connected to the second feed tube of the product bag.

8. A bypass for a tube set having a manifold and a plurality of lines for dispensing a fluid component into a product bag, the bypass comprising:

an inlet fluid passage for connection to one of the lines of the tubing set;

an outlet for receiving a line in fluid communication with the product bag; and

a bypass fluid passage for connection to a line in fluid communication with the manifold,

wherein fluid enters the bypass inlet fluid passageway and exits the outlet only when the outlet is connected to a line in fluid communication with the product bag.

9. The stack of claim 8, wherein the bypass fluid channel forms an angle θ with the inlet fluid channel.

10. The tube set of claim 9, wherein 0 ° < θ < 90 °.

11. The tubing set of claim 8, wherein the outlet includes a flip-top cover to releasably seal the outlet when the outlet is not in use.

12. The tubing set of claim 8, wherein the outlet comprises a silicone membrane for receiving the tubing line in fluid communication with the product bag.

13. A method for selectively dispensing fluid components into a product bag connected to a tube set of a volumetric mixer, the tube set having a plurality of lines, a manifold, and a bypass having a fluid passageway with an inlet and at least two outlets, the method comprising the steps of:

providing fluid components to be dispensed into a product bag, wherein one of the fluid components is maintained separate from the other fluid components;

inserting a line in fluid communication with the product bag into the bypass first outlet;

blocking a bypass second outlet in fluid communication with the manifold; and

the fluid component to be kept separate from the other fluid components is dispensed into the product bag by a bypass independently of the manifold.

14. The method of claim 13, wherein the step of blocking a bypass second outlet in fluid communication with a manifold comprises inserting a hollow probe end of the tubing line in fluid communication with a product bag through the bypass second outlet, thereby blocking the bypass second outlet.

15. The method of claim 13, wherein the fluid component to be kept separate is a lipid solution.