Closed system transfer device and automation system

• US 9,173,816 B2
• Filed: 07/24/2013
• Issued: 11/03/2015
• Est. Priority Date: 07/24/2012
• Status: Active Grant

• Current Assignee: ArXium, Inc. (Van Humbeck Family)
• Original Assignee: Intelligent Hospital Systems, Inc. (Van Humbeck Family)
• Inventors: Reinhardt, Alex H., Rob, Ronald H.
• Primary Examiner(s): Edwards, Jerrah
• Assistant Examiner(s): WEBER, TAMARA L
• Application Number:
  US13/950,061
• Publication Number:
  US 20140031976A1
• Time in Patent Office: 832 Days
• Field of Search: 141/329, 700/239
• US Class Current: 1/1
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

A robotic intravenous automation system, including a robotically controlled holder configured to manipulate an intravenous (IV) bag and a closed system transfer device (CSTD). The controller includes a processor configured to control the holder. The IV bag includes a first fluid port and a second fluid port, and the CSTD includes a CSTD port, a spike adapter that is fluidically separated from the CSTD port, and a flexible member connecting the CSTD port to the spike adapter.

Claims

1. A robotic intravenous automation system, comprising:

a robotically controlled holder configured to manipulate an intravenous (IV) bag and a closed system transfer device (CSTD) that form a CSTD IV bag assembly; and

a controller including a processor configured to control the holder,

wherein

the IV bag includes a first fluid port and a second fluid port,

the CSTD includes a CSTD port, a spike adapter that is fluidically separated from the CSTD port, and a flexible member connecting the CSTD port to the spike adapter,

the spike adapter is connected to the first fluid port of the IV bag, and

the CSTD port is connected to the second fluid port of the IV bag;

wherein the controller is configured to control the holder to perform a process of;

attaching the spike adapter to the first fluid port of the IV bag;

grasping the CSTD port based on a predefined dimensional characteristic of the CSTD port stored in the controller;

manipulating the CSTD port, flexing the flexible member; and

attaching the CSTD port to the second fluid port of the IV bag.

2. The system according to claim 1, wherein the process of further comprises:

accepting a user command to prepare an IV bag with a particular drug;

determining whether the particular drug requires a CSTD;

selecting, by the holder, the CSTD IV bag assembly based on the determining;

attaching a CSTD syringe containing the particular drug to the CSTD port; and

performing a fluid transfer of the particular drug between the CSTD syringe and the IV bag via the CSTD port.

3. The system according to claim 2, wherein the process further comprises:

outputting an indication to place the CSTD IV bag assembly into an inventory rack of the system; and

verifying the CSTD IV bag assembly has been placed into the inventory rack of the system.

4. The system according to claim 3, wherein the verifying includes a visual-based verification by image analysis.

5. The system according to claim 2, wherein the process further comprises:

testing the attachment of the CSTD port to the second fluid port of the IV bag by pulling the CSTD port away from the second fluid port of the IV bag and measuring a amount of force applied in the pulling; and

stopping the testing when the amount of force reaches a predefined amount.

6. The system according to claim 5, wherein the predefined amount is 5, 10, 20, or 40 Ibs.

7. The system according to claim 1, wherein the CSTD port includes an alignment structure that coincides with a particular alignment between the CSTD port and the IV bag, in which the holder and controller can distinguish an alignment of the CSTD IV bag assembly by the alignment structure, and in which the holder can manipulate the CSTD IV bag assembly by the alignment structure.

8. The system according to claim 1, wherein the system further comprises an inventory rack, and wherein the CSTD IV bag assembly is pre-installed into the inventory rack.

9. A closed system transfer device (CSTD) assembly, comprising:

a CSTD port;

a spike adapter that is fluidically separated from the CSTD port;

a flexible member connecting the CSTD port to the spike adapter; and

an IV bag including a first fluid port and a second fluid port;

wherein the spike adapter is connected to the first fluid port of the IV bag;

wherein the CSTD port is connected to the second fluid port of the IV bag; and

wherein the CSTD port includes reverse facing barbs on an interior portion thereof that contacts an exterior of the second fluid port of the IV bag to positively lock the CSTD port to the second fluid port of the IV bag.

10. The CSTD assembly according to claim 9, wherein removing the CSTD port from the second fluid port requires at least 40 lbs of force.

11. The CSTD assembly according to claim 9, wherein the CSTD port includes an alignment structure configured to be grasped by a robotic arm for manipulating the CSTD assembly.

12. The CSTD assembly according to claim 9, wherein the CSTD port includes a cannula, and the spike adapter includes one or two membranes.

13. The CSTD assembly according to claim 9, wherein the flexible member has a relatively long, thin and wide cross section to inhibit selected movement between the CSTD port and the spike adapter.

14. The CSTD assembly according to claim 13, wherein the flexible member resists a relative twisting motion between the CSTD port and the spike adapter, so that the CSTD port and the spike adapter have a natural un-stressed position of having parallel axes, with respect to a long axis of each of the CSTD port and the spike adapter.

15. A closed system transfer device (CSTD) assembly, comprising:

a CSTD port, wherein the CSTD port includes a cannula;

a spike adapter that is fluidically separated from the CSTD port, wherein the spike adapter includes one or two membranes; and

a flexible member connecting the CSTD port to the spike adapter.

16. The CSTD assembly according to claim 15, further comprising an IV bag including a first fluid port and a second fluid port;

wherein the spike adapter is connected to the first fluid port of the IV bag; and

wherein the CSTD port is connected to the second fluid port of the IV bag.

17. The CSTD assembly according to claim 15, wherein the CSTD port includes an alignment structure configured to be grasped by a robotic arm for manipulating the CSTD assembly.

18. The CSTD assembly according to claim 15, wherein the flexible member has a relatively long, thin and wide cross section to inhibit selected movement between the CSTD port and the spike adapter.

19. The CSTD assembly according to claim 15, wherein the flexible member resists a relative twisting motion between the CSTD port and the spike adapter, so that the CSTD port and the spike adapter have a natural un-stressed position of having parallel axes, with respect to a long axis of each of the CSTD port and the spike adapter.

20. An IV bag assembly, comprising:

an IV bag including a first fluid port and a second fluid port, wherein the IV bag has a horizontal plane, a vertical plane, and a normal plane;

wherein the normal plane is perpendicular with respect to the horizontal and vertical planes; and

a closed system transfer device (CSTD) comprising

a spike adapter connected to the first fluid port of the IV bag,

a CSTD port that is fluidically separated from the spike adapter and that is connected to the second fluid port of the IV bag; and

a flexible member connecting the spike adapter and the CSTD port;

wherein the flexible member can move between the first fluid port and the second fluid port in the longitudinal plane and the vertical plane and is relatively stiff in the normal plane.

21. The CSTD assembly according to claim 20, wherein the flexible member has a relatively long, thin and wide cross section to inhibit selected movement between the CSTD port and the spike adapter.

22. The CSTD assembly according to claim 20, wherein the flexible member resists a relative twisting motion between the CSTD port and the spike adapter, so that the CSTD port and the spike adapter have a natural un-stressed position of having parallel axes, with respect to a long axis of each of the CSTD port and the spike adapter.

23. The CSTD assembly according to claim 20, wherein the CSTD port comprises a cannula.

24. The CSTD assembly according to claim 20, wherein the CSTD port comprises an alignment structure configured to be grasped by a robotic arm for manipulating the CSTD assembly.