Radiopharmaceutical delivery device

• US 9,039,592 B2
• Filed: 03/14/2013
• Issued: 05/26/2015
• Est. Priority Date: 06/07/2012
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Medical Care Inc. (Bayer AG)
• Inventors: Kaintz, Ryan, Bazala, Jason L., Griffith, Scott R., Fazi, Bruno, Marsh, Charles, Agamaite, James A., Sass, Matthew, Beale, Matthew, DeScalzi, Douglas, Benson, Carl Michael, Southard, Courtney N.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/828,987
• Publication Number:
  US 20130331634A1
• Time in Patent Office: 803 Days
• Field of Search: 600 1- 8, 604/131, 604/258, 604/284
• US Class Current: 600/4
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/84 for treating several patients simultaneously
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy

Abstract

A device for delivery of a radiopharmaceutical and, in some embodiments, delivery of a pharmaceutical agent are provided herein. A fluid path set comprising a confluence valve, a four-way valve, and one or more tubing sections which are designed to place some combination of a radiopharmaceutical source, a medical fluid source, and a pharmaceutical agent source in sterile fluid communication with a patient or a waste receptacle. Also provided are holders for the fluid path set, and a sterile fluid delivery kit comprising the holder and fluid path set. A fluid delivery system may accept the holder with the fluid path set installed and various sources of radiopharmaceuticals, pharmaceuticals, and medical fluids. The fluid delivery system allows for automated mixing and delivery of exact amounts of these agents to a patient while improving efficiency and safety, and reducing waste.

Claims

1. A fluid path set for use in a fluid delivery system, the fluid path set comprising:

a confluence valve;

a four-way valve;

a first tubing section in fluid communication with a first input and the confluence valve;

a second tubing section in fluid communication with a second input and the confluence valve;

a third tubing section in fluid communication with the confluence valve and the four-way valve;

an output tubing section in fluid communication with the four-way valve and at least one output fitting;

a waste tubing section in fluid communication with the four-way valve and at least one waste receptacle; and

an auxiliary tubing section in fluid communication with the four-way valve and the confluence valve.

2. The fluid path set of claim 1, further comprising a coil assembly disposed between the confluence valve and the four-way valve in fluid communication with at least the third tubing section.

3. The fluid path set of claim 1, further comprising a medical fluid storage container coupled to the first input.

4. The fluid path set of claim 3, wherein the medical fluid storage container comprises a cylindrical device having a plunger slidably inserted into the medical fluid storage container creating a seal.

5. The fluid path set of claim 3, further comprising a connector configured to connect to a fluid reservoir in fluid communication with the medical fluid storage container.

6. The fluid path set of claim 1, wherein the second input comprises a vial spike.

7. The fluid path set of claim 1, further comprising a pharmaceutical delivery port in fluid communication with the output tubing section.

8. The fluid path set of claim 1, wherein the at least one waste receptacle comprises an IV bag.

9. The fluid path set of claim 1, further comprising one or more of joints, linear joints, T-joints, 4-way joints, valves, check valves, by-pass valves, stop cocks, linkers, luer linkers, screw-type linkers, pressure fittings, and combinations thereof.

10. The fluid path set of claim 1, wherein each of the first tubing section, the second tubing section, the third tubing section, the output tubing section, the waste tubing section, and the auxiliary tubing section are permanently attached to at least one of the confluence valve and the four-way valve.

11. The fluid path set of claim 1, wherein the first input, the second input, the output fitting, or combinations thereof comprise a swabable valve.

12. The fluid path set of claim 1, further comprising:

a portable tray operably coupled to the fluid path set, wherein the portable tray is configured to hold and separate components of the fluid path set.

13. The fluid path set of claim 12, wherein the portable tray comprises a rigid material.

14. The fluid path set of claim 12, wherein the portable tray comprises multiple grooves designed and configured to accept one or more of the first tubing section, the second tubing section, the third tubing section, the output tubing section, the waste tubing section, and the auxiliary tubing section.

15. The fluid path set of claim 12, wherein the portable tray comprises one or more openings.

16. The fluid path set of claim 12, wherein the portable tray comprises a vial spike permanently attached to a portion of the portable tray.

20. The fluid path set of claim 2, wherein the coil assembly comprises a tubing section formed in a helical coil of between about 5 and about 7 turns of a portion of the third tubing section.

21. The fluid path set of claim 20, wherein the coil assembly further comprises a core structure around which the helical coil is formed, the core structure comprising an upper shoulder and a lower shoulder that define a tube channel therebetween, the upper and lower shoulders adapted to retain the helical coil therebetween within the tube channel.

17. A portable fluid path set tray comprising:

an upper side and a lower side;

multiple grooves on the upper side designed and configured to accept and separate components of a fluid path set, wherein the components of the fluid path set comprise a first tubing section, a second tubing section, a third tubing section, an output tubing section, a waste tubing section, and an auxiliary tubing section; and

a vial spike permanently attached to the tray.

18. The portable fluid path set tray of claim 17, wherein the tray comprises a rigid material.

19. The portable fluid path set tray of claim 17, further comprising one or more handles.

22. The portable fluid path set tray of claim 17, wherein the tray further comprises grooves or openings designed and configured to accept a confluence valve and a four-way valve,

wherein the confluence valve is in fluid communication with the first tubing section, the second tubing section, and the third tubing section, and wherein the four-way valve is in fluid communication with the third tubing section, the output tubing section, the waste tubing section, and the auxiliary tubing section.

23. A sterile fluid delivery kit comprising:

a fluid path set including;

a confluence valve,

a four-way valve,

a first tubing section in fluid communication with a first input and the confluence valve,

a second tubing section in fluid communication with a second input and the confluence valve,

a third tubing section in fluid communication with the confluence valve and the four-way valve,

an output tubing section in fluid communication with the four-way valve and at least one output fitting,

a waste tubing section in fluid communication with the four-way valve and at least one waste receptacle, and

an auxiliary tubing section in fluid communication with the four-way valve and the confluence valve;

a portable fluid path set tray composed of a rigid material and operably coupled to the fluid path set, wherein the fluid path set tray comprises;

an upper side and a lower side,

multiple grooves on the upper side designed and configured to accept and separate components of the fluid path set, and

a vial spike permanently attached to the portable fluid path set tray; and

a package defining an interior space adapted to house the fluid path set and the portable fluid path set tray,

wherein the interior space of the package, the fluid path set, and the portable fluid path set tray are sterile.

24. The sterile delivery kit of claim 23, wherein the portable fluid path set tray further comprises:

a medical fluid storage container coupled to the first input; and

a coil assembly disposed between the confluence valve and the four-way valve in fluid communication with at least the third tubing section.