COMPOUNDING DEVICE, SYSTEM, KIT, SOFTWARE, AND METHOD

• US 20160310363A1
• Filed: 04/30/2015
• Published: 10/27/2016
• Est. Priority Date: 04/23/2015
• Status: Active Grant

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Ammermann, Linda M., Konrad, Karl Jr., Bartholomew, Joel, Janders, Mike, Lane, Benjamin R., Mumpower, Mariano, Pearl, Aaron S.
• Granted Patent: US 9,802,171 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61J 2200/70 Device provided with specific sensor or indicating means
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2039/229 Stopcocks
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: B01F 2101/06 Mixing of food ingredients
• CPC Class Codes: B01F 2101/22 Mixing of ingredients for pharmaceutical or medical compositions
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 2101/2204 Mixing chemical components in generals in order to improve chemical treatment or reactions, independently from the specific application
• CPC Class Codes: B01F 23/45 using flow mixing
• CPC Class Codes: B01F 23/451 by injecting one liquid into another
• CPC Class Codes: B01F 25/1051 of the mixing valve type
• CPC Class Codes: B01F 25/30 Injector mixers mixing by creating vortex flow B01F25/10
• CPC Class Codes: B01F 25/31 in conduits or tubes through which the main component flows
• CPC Class Codes: B01F 33/30 Micromixers
• CPC Class Codes: B01F 33/3017 Mixing chamber
• CPC Class Codes: B01F 33/84 Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
• CPC Class Codes: B01F 33/846 using stored recipes for determining the composition of the mixture to be produced, i.e. for determining the amounts of the basic components to be dispensed from the component receptacles
• CPC Class Codes: B01F 35/7176 using pumps
• CPC Class Codes: B01F 35/717611 : Peristaltic pumps
• CPC Class Codes: B01F 35/71805 : using valves, gates, orifices or openings
• CPC Class Codes: B65B 3/12 : mechanically, e.g. by pistons or pumps
• CPC Class Codes: F16K 11/085 : with cylindrical plug
• CPC Class Codes: F16K 11/0856 : having all the connecting conduits situated in more than one plane perpendicular to the axis of the plug
• CPC Class Codes: F16K 11/22 : with an actuating member for each valve, e.g. interconnected to form multiple-way valves
• CPC Class Codes: F16K 2099/0084 : Chemistry or biology, e.g. "lab-on-a-chip" technology
• CPC Class Codes: F16K 31/041 : for rotating valves F16K31/055 takes precedence
• CPC Class Codes: F16K 5/04 : with plugs having cylindrical surfaces; Packings therefor
• CPC Class Codes: F16K 5/0407 : with particular plug arrangements, e.g. particular shape or built-in means
• CPC Class Codes: F16K 5/0414 : Plug channel at 90 degrees to the inlet
• CPC Class Codes: F16K 99/0013 : Rotary valves
• CPC Class Codes: F16K 99/0042 : Electric operating means therefor

Abstract

An exemplary compounding system and method can include a transfer set that includes a manifold for assisting in transferring a plurality of ingredients from supply container(s) to a final container. The manifold can include a first channel in fluid communication with at least one primary ingredient, and a second channel in fluid communication with a plurality of secondary ingredients. The first channel and second channel can be in fluid isolation from each other such that the at least one primary ingredient does not mix with the plurality of secondary ingredients within the manifold. The transfer set can include a plurality of inlet lines in fluid communication with the manifold and two outlet lines configured for connection to two separate pumps and eventually being in fluid communication with the final container.

Claims

1. A manifold for a compounding device, comprising:

a housing;

at least one primary intake port located on the housing and including a primary valve configured to open and close the at least one primary intake port to permit or refuse passage of at least one primary ingredient through the manifold;

a plurality of secondary intake ports located on the housing, each of the secondary intake ports including a secondary valve configured to open and close a respective one of the plurality of secondary intake ports to permit or refuse passage of a plurality of secondary ingredients through the manifold;

a first channel in fluid communication with the at least one primary valve and including an outlet port configured to outlet the at least one primary ingredient from the manifold; and

a second channel in fluid communication with the plurality of secondary valves and including an outlet port configured to outlet at least one of the plurality of secondary ingredients from the manifold, wherein the first channel and second channel are in fluid isolation from each other such that the at least one primary ingredient does not mix with the plurality of secondary ingredients within the manifold.

2. The manifold of claim 1, wherein a cross-sectional area of a fluid pathway defined by the first channel and taken normal to a longitudinal axis of the first channel is smaller than a cross-sectional area of a fluid pathway defined by the second channel and taken normal to a longitudinal axis of the second channel.

3. The manifold of claim 1, wherein the manifold includes a filler located in the first channel and is configured to reduce a cross-sectional area taken normal to a longitudinal axis of the first channel.

4. The manifold of claim 1, wherein the at least one primary intake port is configured to be connected to at least one primary connection line, and the plurality of secondary intake ports are configured to be connected to a respective one of a plurality of secondary connection lines, wherein a cross-sectional area taken normal to a longitudinal axis of the at least one primary connection line is smaller than a cross-sectional area taken normal to a longitudinal axis for each of the plurality of secondary connection lines.

5. The manifold of claim 1, wherein the at least one primary intake port has a cross-sectional area normal to an axis in which fluid travels that is smaller than a cross-sectional area normal to an axis in which fluid travels in each of the plurality of secondary intake ports.

6. The manifold of claim 1, wherein the at least one primary valve is located adjacent and in fluid communication with the first channel of the manifold, and the secondary valves are located adjacent and in fluid communication with the second channel of the manifold.

7. The manifold of claim 6, further comprising a filler rod extending into the first channel to reduce a cross-sectional area in which fluid flows, the cross-sectional area taken normal to a longitudinal axis of the first channel.

8. The manifold of claim 7, wherein an inner diameter of the first channel is equal to an inner diameter of the second channel.

9. The manifold of claim 6, wherein the first channel includes a socket located at an end opposite an output port of the first channel.

10. The manifold of claim 9, further comprising a filler extending from the socket towards the output port of the first channel.

11. The manifold of claim 1, wherein the at least one primary intake port includes a plurality of primary intake ports, a first plurality of the primary intake ports having a primary diameter and a second plurality of the primary intake ports having a secondary diameter, and the primary diameter being smaller than the secondary diameter.

12. The manifold of claim 11, wherein each of the plurality of secondary intake ports has a diameter substantially equal to the secondary diameter.

13. The manifold of claim 1, further comprising a sensor configured to confirm that the housing is in a correct and operational position with respect to the compounding device.

14. The manifold of claim 1, wherein at least one of the at least one primary valve and the secondary valves includes a wall configured to require fluid to turn greater than 90 degrees along a fluid pathway after entering a valve inlet and prior to exiting a side outlet of the at least one of the at least one primary valve and the secondary valves.

15. The manifold of claim 1, wherein the housing of the manifold includes an attachment structure configured to removeably attach the housing of the manifold to a housing of the compounding device.

16. The manifold of claim 15, wherein the primary valve includes a mating structure configured to mate with a primary actuator member located on the compounding device when the manifold is attached to the housing of the compounding device, and each of the secondary valves includes a mating structure configured to mate with a secondary valve actuator member located on the compounding device when the manifold is attached to the housing of the compounding device.

17. The manifold of claim 1, further comprising:

at least one primary valve actuator connection structure located adjacent the housing and configured to mate with and be actuated by at least one actuator located on the compounding device; and

a plurality of secondary valve actuator connection structures located adjacent the housing and configured to mate with at least one secondary actuator located on the compounding device.

18. A transfer set for a compounding device, comprising:

a housing;

at least one primary flexible input line connected to the housing via a primary valve configured to permit or refuse passage of at least one primary ingredient from the at least one primary flexible input line through the housing;

a plurality of secondary flexible input lines connected to the housing via at least one secondary valve configured to permit or refuse passage of a plurality of secondary ingredients from the secondary flexible input lines through the housing;

a first channel defined by the housing and in fluid communication with the at least one primary flexible input line and including an outlet port configured to outlet the at least one primary ingredient from the housing;

a second channel defined by the housing and in fluid communication with the plurality of secondary flexible input lines and including an outlet port configured to outlet the plurality of secondary ingredients from the housing;

at least one primary flexible output line connected to the outlet port of the first channel, the housing configured such that the at least one primary ingredient is transported away from the housing via the at least one primary flexible output line during use of the transfer set; and

at least one secondary flexible output line connected to the outlet port of the second channel, the housing configured such that the plurality of secondary ingredients are transported away from the housing via the at least one secondary flexible output line during use of the transfer set.

19. The transfer set of claim 18, wherein a cross-sectional area of a fluid pathway defined by the first channel and taken normal to a longitudinal axis of the first channel is smaller than a cross-sectional area of a fluid pathway defined by the second channel and taken normal to a longitudinal axis of the second channel.

20. The transfer set of claim 18, further comprising a filler located in the first channel and configured to reduce a cross-sectional area taken normal to a longitudinal axis of the first channel.

21. The transfer set of claim 18, wherein a cross-sectional area taken normal to a longitudinal axis of the at least one primary flexible input line is smaller than a cross-sectional area taken normal to a longitudinal axis for each of the plurality of secondary flexible input lines.

22. The transfer set of claim 20, wherein an inner diameter of the first channel is equal to an inner diameter of the second channel.

23. The transfer set of claim 18, wherein the first channel includes a socket located at an end opposite an output port of the first channel.

24. The transfer set of claim 23, further comprising a filler extending from the socket towards the output port of the first channel.

25. The transfer set of claim 18, wherein the at least one primary valve includes a wall configured to require fluid to turn greater than 90 degrees along a fluid pathway after entering a valve inlet and prior to exiting a side outlet of the at least one primary valve.

26. The transfer set of claim 18, wherein the housing includes an attachment structure configured to removeably attach the housing of the transfer set to a housing of the compounding device.

27. The transfer set of claim 26, wherein the primary valve includes a mating structure configured to mate with a primary actuator member located on the compounding device when the transfer set housing is attached to the housing of the compounding device, and each of the secondary valves includes a mating structure configured to mate with a secondary valve actuator member located on the compounding device when the transfer set housing is attached to the housing of the compounding device.

28. The transfer set of claim 18, further comprising a sensor configured to confirm that the housing is in a correct and operational position with respect to the compounding device.

29. The transfer set of claim 18, further comprising a strain relief connected to both of the at least one primary flexible output line and the at least one secondary flexible output line.

30. The transfer set of claim 18, further comprising a union junction connected to both the at least one primary flexible output line and the at least one secondary flexible output line, the union junction configured to join a fluid path defined by the at least one primary flexible output line with a fluid path defined by the at least one secondary flexible output line.

31. The transfer set of claim 30, further comprising a strain relief located between the housing and the union junction and connected to both of the at least one primary flexible output line and the at least one secondary flexible output line.

32. The transfer set of claim 18, further comprising a combined fluid line configured to receive fluid from both the at least one primary flexible output line and the at least one secondary flexible output line, the combined fluid line including an attachment structure for connection to a final container.

33. The transfer set of claim 18, further comprising:

a branch junction connected to the at least one secondary flexible input line; and

a flex line connected to the branch junction and in fluid communication with the first channel such that a portion of the at least one secondary flexible input line located upstream of the branch junction is in fluid communication with both the first channel and the second channel.

34. A method for using a transfer set with a compounding device, comprising:

providing the transfer set that includes a housing with at least one primary intake port and at least one secondary intake port, a first flexible output line extending from the housing, and a second flexible output line extending from the housing;

providing the compounding device that includes a housing, a first pump, and a second pump;

connecting the housing of the transfer set to the housing of the compounding device;

leading the first flexible output line onto the first pump to attach the first flexible output line to the first pump; and

leading the second flexible output line onto the second pump to attach the second flexible output line to the second pump.

35. The method of claim 34, further comprising:

providing at least one first flexible input line, and a plurality of second flexible input lines on the housing;

connecting the first flexible input line to a first source container; and

connecting at least one of the second flexible input lines to a second source container.

36. The method of claim 35, wherein a cross-sectional diameter taken normal to a flow path of the first flexible input line is different in size as compared to a cross-sectional diameter taken normal to a flow path of the at least one of the second flexible input lines.

37. The method of claim 34, further comprising:

causing a first fluid to flow through the housing of the transfer set along a first channel; and

causing a second fluid and third fluid different from the second fluid to flow through the housing of the transfer set along a second channel that is different from and separated from the first channel such that the first fluid does not mix with the second fluid and third fluid while in the housing, and such that the second fluid and third fluid mix within the housing.