Delivery methods, systems and components for use with hazardous pharmaceutical substances

• US 20040260143A1
• Filed: 07/16/2004
• Published: 12/23/2004
• Est. Priority Date: 06/29/2001
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Reilly, David M., Griffiths, David M., Hirschman, Alan D., Crookston, Currie
• Granted Patent: US 7,204,797 B2
• Time in Patent Office: Days
• US Class Current: 600/5
• 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 of dispensing a hazardous pharmaceutical comprising the steps of: connecting a source of flushing fluid to a first port of a fluid delivery set; connecting a pressurizing unit of a powered injector system (including a powered injector and the pressurizing unit) to a second port of the fluid delivery set; purging air from the fluid delivery set; and, after purging air from the fluid delivery set, connecting a third port of the fluid delivery set to a source of the hazardous pharmaceutical. The fluid delivery set can, for example, include a valve system or assembly to control flow of fluid through the fluid delivery set. A system for delivery of a hazardous pharmaceutical includes: a syringe in operative connection with a powered injector; a protective container to enclose the syringe during operation thereof; the protective container being adapted to protect personnel from detrimental effects of the pharmaceutical; at least one source of flushing fluid; a fluid path adapted to connect to a patient; at least one source of the pharmaceutical; 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 pharmaceutical are removably connectable. The valve assembly provides 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 pharmaceutical to the fluid delivery set.

Claims

1. A method of injecting a hazardous pharmaceutical, said method 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 to a second port of the fluid delivery set, the powered injector system including a powered injector and the pressurizing unit;

(c) purging air from the fluid delivery set; and

(d) after purging air from the fluid delivery set, connecting a third port of the fluid delivery set to a source of the hazardous pharmaceutical.

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 wherein further including the steps of removably connecting a disposable fluid path adapted to connect to a patient to the fluid delivery set and purging air from the disposable fluid path before connecting the fluid delivery set to the source of hazardous pharmaceutical.

4. The method of claim 3 wherein the pressurizing unit is a syringe in operative connection with the powered injector, the method further including the steps of drawing hazardous pharmaceutical into the syringe and injecting the hazardous pharmaceutical through the fluid delivery set and the disposable fluid path.

5. The method of claim 4 further including the step of flushing the fluid delivery set and the disposable fluid path after injection using the flushing fluid.

6. The method of claim 4 wherein the hazardous pharmaceutical is a radiopharmaceutical, the method further including the step of measuring the level of radioactivity of the radiopharmaceutical dispensed.

7. The method of claim 6 wherein the level of radioactivity is measured by positioning a radioactivity detector in operative proximity to the syringe.

8. The method of claim 6 wherein the level of radioactivity is measured by placing a radioactivity detector in operative connection with a line through which the radiopharmaceutical is dispensed.

9-15. -15. (Canceled)

16. An adapter for use with a powered injector to attach a syringe to the powered injector, said adapter comprising:

(a) an injector attachment member to attach the adapter to the powered injector; and

(b) a syringe attachment member spaced from the injector attachment member by a sufficient distance to position the syringe attached to the syringe attachment member in operative proximity to a radioactivity detector, the syringe being oriented with a tip thereof directed toward the powered injector when attached to the syringe attachment member.

17. An adapter for use with a powered injector to attach a syringe to the powered injector, said adapter comprising:

(a) an injector attachment member to attach the adapter to the powered injector;

(b) a plunger extension fixed in position relative to the powered injector and having a plunger attachment member to attach to a plunger of the syringe; and

(c) a syringe carriage slidably attached to the adapter, the syringe carriage including a syringe attachment member to removably attach the syringe thereto so that a barrel of the syringe can be moved relative to the plunger thereof to control fluid flow into and out of the syringe.

18. The adapter of claim 17 wherein a syringe is oriented with a syringe tip thereof directed toward the powered injector when attached to the syringe attachment member.

19. An adapter for use with a powered injector to attach a syringe to the powered injector comprising:

an attachment member to removably attach the adapter to a powered injector, a syringe carriage slidably attached to the attachment member, the syringe carriage including a syringe attachment member to which a syringe can be removably attached, the adapter further including an end member attached a fixed distance from the attachment member, the end member having a plunger extension attached to the end member and extending toward the injector, the plunger extension including a plunger attachment member on an end thereof opposite the end attached to the end member, the syringe carriage adapted to move a barrel of the syringe relative to a plunger of the syringe when a syringe is attached to the syringe attachment member and a plunger thereof is attached to the plunger extension member.

20. 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.

21. A method of injecting a radiopharmaceutical into a body, said method including the steps of:

(a) 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; and

(b) 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.

22. The method of claim 21 wherein the second volume is less than the first volume.

23. The method of claim 21 wherein the pressurizing device is a syringe in fluid connection with a powered injector.

24-31. -31. (Canceled)