Delivery methods, systems and components for use with radiopharmaceutical substances

• US 20050238576A1
• Filed: 02/15/2005
• Published: 10/27/2005
• Est. Priority Date: 06/29/2001
• Status: Abandoned Application

• Current Assignee: Erik Witt, Mary Anne Dell
• Original Assignee: Erik Witt, Mary Anne Dell
• Inventors: Witt, Erik, Dell, Mary Anne
• Application Number:
  US11/058,840
• Publication Number:
  US 20050238576A1
• Time in Patent Office: Days
• US Class Current: 424/1.110
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/1785 comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A method and apparatus of dispensing a radiopharmaceutical wherein a source of flushing fluid is connected to a first port of a fluid delivery set; a pressurizing unit of a powered injector system (including a powered injector and the pressurizing unit) is connected to a second port of the fluid delivery set; air is purged from the fluid delivery set; and, after purging air from the fluid delivery set, a third port of the fluid delivery set is connected to a source of the radiopharmaceutical. A valve system is included to control flow of fluid. A syringe is operatively connected with a powered injector. A radioactive shield encloses the syringe during operation to protect personnel from detrimental effects. A dose calibrator measure the radioactivity in the syringe.

Claims

1. A method of injecting a radiopharmaceutical comprising the steps of:

(a) connecting a source of flushing fluid to a first port of a fluid delivery set;

(b) connecting a pressurizing unit of a powered injector system including a syringe in operative connection with the powered injector, to a second port of the fluid delivery set, the powered injector system including a powered injector and the pressurizing unit;

(c) removably connecting a disposable fluid path adapted to connect to a patient to the fluid delivery set;

(d) purging air from the fluid delivery set and the disposable fluid path;

(e) after purging air in step (d), connecting a third port of the fluid delivery set to a source of the radiopharmaceutical;

(f) drawing radiopharmaceutical into the syringe and injecting the radiopharmaceutical through the fluid delivery set and the disposable fluid path; and

(g) measuring the level of radioactivity of the radiopharmaceutical dispensed.

2. The method of claim 1 wherein the fluid delivery set includes a valve system to control flow of fluid through the fluid delivery set.

3. The method of claim 1 further including the step of flushing the fluid delivery set and the disposable fluid path after injection using the flushing fluid.

4. The method of claim 1 wherein the level of radioactivity is measured by positioning the syringe within a dose calibrator.

5. The method of claim 1 wherein the level of radioactivity is measured by placing a radioactivity detector in operative connection with a line through which the radiopharmaceutical is dispensed.

6. A system for delivery of a radiopharmaceutical:

a syringe in operative connection with a powered injector;

a dose calibrator adapted to measure the level of radioactivity of the radiopharmaceutical within the syringe, and including as a component thereof a protective container to enclose the syringe during operation thereof, the protective container being adapted to protect personnel from detrimental effects of the radiopharmaceutical;

at least one source of flushing fluid;

a fluid path adapted to connect to a patient;

at least one source of the radiopharmaceutical; and

a fluid delivery set including a valve assembly to which the syringe, the source of flushing fluid, the fluid path and the source of radiopharmaceutical are removably connectable, the valve assembly providing flow control through the fluid delivery set such that operator contact with the fluid delivery set is not required after connection of the source of radiopharmaceutical to the fluid delivery set.

7. The system of claim 6 wherein valve assembly provides flow control through the fluid delivery set such that the entire fluid delivery set can be purged of air with the syringe and the source of flushing fluid in fluid connection with the valve assembly before the scarce of pharmaceutical is connected to the fluid delivery set.

8. The system of claim 6 wherein the valve assembly includes a bypass line in continuous fluid connection between the source of flushing fluid and the fluid path.

9. The system of claim 6 wherein the syringe is connected to the powered injector via an extending adapter.

10. The system of claim 9 wherein the adapter extends from the powered injector when connected thereto to position the syringe within the protective container.

11. The system of claim 10 wherein the adapter includes an injector attachment member to attach the adapter to a powered injector, a plunger extension fixed in position relative to a powered injector and having a plunger attachment member to attach to a plunger of the syringe, a syringe carriage slidably attached to the adapter, the syringe carriage including a syringe attachment member to removably attach a syringe thereto so that a barrel of a syringe can be moved relative to a plunger thereof to control fluid flow into and out of a syringe.

12. The adapter of claim 11 wherein a syringe is oriented with a syringe tip thereof directed toward the powered injector when the syringe is attached to the syringe attachment member.

13. A method of using a powered injector system to inject a radiopharmaceutical into a body comprising the steps of:

attaching an extending adapter to the front end of the powered injector;

the adapter including an injector attachment to place the adapter in operative connection with the powered injector, the adapter also including a syringe attachment to attach a syringe to the adapter to place the syringe in operative connection with the powered injector;

extending the adapter into a radiation shield.

14. The method of claim 13 wherein in the radiation shield is a dose calibrator to measure the radioactivity of radiopharmaceutical within the syringe

15. The method of claim 13 wherein the syringe is oriented generally vertically when the syringe is placed within the radiation shield.

16. The method of claim 15 wherein an exit of the syringe is oriented upward.

17. The combination of a radiation dose calibrator and an adapter for use with a powered injector to attach a syringe to the powered injector comprising:

an injector attachment member to attach the adapter to a powered injector and a syringe attachment member spaced from the injector attachment member by a sufficient distance to position a syringe attached to the syringe attachment member within the radiation dose calibrator.

18. A shield for use with a radiopharmaceutical, the shield including a housing that is impenetrable by radioactive energy from the radiopharmaceutical, the shield also including at least one opening in the housing through which an article containing the radiopharmaceutical and positioned within the housing can be viewed, the opening being in visual alignment with a reflective surface in which a viewer can view a reflection of the article, the opening being positioned within the housing such that there is no direct line between the viewer and the article that is not shielded by a portion of the housing.

19. A method of injecting a radiopharmaceutical into a body including the steps of:

positioning a pressurizing device containing a first volume of the radiopharmaceutical within a dose calibrating unit adapted to measure the level of radioactivity of the radiopharmaceutical;

injecting a second volume of the radiopharmaceutical, the second volume being determined through measurement by the dose calibrating unit to provide a desired level of radioactivity.

20. The method of claim 19 wherein the second volume is less than the first volume.

21. The method of claim 19 wherein pressurizing chamber is a syringe in fluid connection with a powered injector.

22. A method of injecting a radiopharmaceutical into a patient comprising the steps of:

connecting a powered pressurizing device that is controlled without close operator contact to a valve assembly of a fluid delivery set;

connecting at least one source of a flushing fluid the valve assembly;

connecting a patient fluid path to the valve assembly, the patient fluid path terminating in a patient connector;

connecting a ready-made source of the radiopharmaceutical to the valve assembly;

controlling the valve assembly at least during injection of the radiopharmaceutical such that operator presence in the vicinity of the radiopharmaceutical is not required;

purging all lines of the fluid delivery set of air before connecting the source of radiopharmaceutical to the valve assembly; and

shielding at least a portion of the pressurizing device that contacts the radiopharmaceutical,

23. The method of claim 22 further including the step of shielding at least a portion of the fluid delivery set.

24. The method of claims 22 further including the step of measuring the radioactivity of a dose of radiopharmaceutical delivered to the patient generally simultaneously with injecting the radiopharmaceutical.

25. The method of claim 22 wherein the valve assembly is controlled without close operator contact.