Fluid delivery systems, devices and methods for delivery of hazardous fluids

• US 9,005,166 B2
• Filed: 05/21/2013
• Issued: 04/14/2015
• Est. Priority Date: 04/08/2003
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Medical Care Inc. (Bayer AG)
• Inventors: Uber, Arthur E. III, Hirschman, Alan D., Griffiths, David M., Trombley, Frederick W. III, Reilly, David M.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/898,680
• Publication Number:
  US 20130253254A1
• Time in Patent Office: 693 Days
• Field of Search: 250/505.1, 250/506.1, 250/507.1, 604/82, 604/905, 604/131, 604 65- 67, 604/151, 128/DIG.1, 128/DIG.12, 128/DIG.13
• US Class Current: 604/131
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy

Abstract

A system for delivering fluid to a patient includes a hazardous material enclosure suitable for holding a first container comprising a first fluid, and a pump device capable of pumping the first fluid from the first container and a second fluid from a second container. The hazardous materials enclosure has a cap which includes a flexible sealing member that cooperates with the first container to create a biohazard seal during connection of the first container to the cap. The system further includes a mixing device associated with the pump for mixing the first and second fluids for delivering the fluid mixture to the patient.

Claims

1. A system for delivering a fluid to a patient, the system comprising:

a hazardous material enclosure suitable for holding a first container comprising a first fluid, wherein the enclosure comprises a cap including a flexible sealing member and a conduit;

a pump device having a pump body, wherein the pump device is capable of pumping the first fluid from the first container and a second fluid from a second container;

a fluid path operably connected to the pump device; and

a mixing device associated with the pump device for mixing the first fluid and the second fluid for delivering a fluid mixture of the first fluid and the second fluid to the patient,

wherein the flexible sealing member cooperates with the first container to create a biohazard seal during connection of the first container to the cap, and the conduit is configured to make a fluid connection with the first container and the fluid path, and

wherein the enclosure is adapted to be removeably attachable to the pump device.

2. The system of claim 1, wherein the first fluid comprises a radiopharmaceutical fluid and the enclosure is radiation shielded.

3. The system of claim 1, wherein the enclosure comprises a heating/cooling element for heating/cooling the first fluid.

4. The system of claim 1, wherein the enclosure is adapted to be removeably attachable to the pump device via a release latch.

5. The system of claim 1, wherein the pump device comprises controls positioned on the pump body to control operation of the pump device.

6. The system of claim 1, further comprising a remote control device associated with the pump device to control operation of the pump device.

7. The system of claim 1, wherein the enclosure is disposable.

8. The system of claim 1, wherein the first fluid comprises a hazardous pharmaceutical fluid and the second fluid comprises a diluent fluid.

9. The system of claim 1, wherein the mixing device comprises a sterile tubing set for mixing the first fluid and the second fluid.

10. The system of claim 1, wherein the pump device is manually operated.

11. The system of claim 1, wherein the pump device comprises a powered injector device.

12. The system of claim 1, further comprising:

a waste container in fluid connection with the fluid path, wherein the waste container is suitable to contain a hazardous material.

13. The system of claim 1, wherein the fluid path comprises a catheter having two lumens arranged such that flow from the outer lumen substantially surrounds flow from the inner lumen.

14. The system of claim 1, wherein the fluid path comprises a catheter adapted to terminate in a blood vessel of the patient.

15. The system of claim 1, wherein the flexible sealing member is circumferential.

16. The system of claim 1, wherein the flexible sealing member is axially compressed during connection of the first container to the enclosure.

17. The system of claim 1, wherein the hazardous material enclosure further comprises:

a first septum configured to seal a port into the first container and a second septum sealing the port, the second septum being spaced from the first septum.

18. A method for delivering a fluid mixture to a patient, the method comprising:

removeably attaching a hazardous material enclosure to a pump device, wherein the enclosure comprises a cap including a flexible sealing member and a conduit;

attaching a first container suitable for holding a first fluid in the enclosure, wherein the first fluid is a hazardous fluid and the flexible sealing member cooperates with the first container to create a biohazard seal during connection of the first container to the cap, and the conduit is configured to make a fluid connection with the first container;

removeably attaching a second container suitable for holding a second fluid to the pump device;

pumping the first fluid from the first container and the second fluid from the second container with the pump device;

mixing the first fluid and the second fluid in a mixing device associated with the pump device to create a fluid mixture; and

delivering the fluid mixture to the patient.

19. The method of claim 18, wherein the mixing device comprises a sterile tubing set for mixing the first fluid and the second fluid.

20. The method of claim 18, wherein the first fluid comprises a radiopharmaceutical fluid and the second fluid comprises a diluent fluid.

21. The method of claim 18, further comprising:

heating or cooling the first fluid using a heating/cooling element associated with the enclosure.

22. The method of claim 18, further comprising:

controlling operation of the pump device with controls positioned on a body portion of the pump device.

23. An enclosure for containing a hazardous fluid, the enclosure comprising:

a circumferential flexible sealing member on an outer surface of a neck portion of the enclosure, wherein the sealing member cooperates with a connector to create a biohazard seal during connection of the enclosure to the connector;

wherein the sealing member is axially compressed during connection of the enclosure to the connector, and wherein an inner surface of the connector comprises at least one elastomeric thread that interacts with the sealing member.

24. The enclosure of claim 23, further comprising:

a first septum sealing a port into the enclosure and a second septum sealing the port, the second septum being spaced from the first septum.