DEVICES, SYSTEMS AND METHODS FOR DETECTING INCREASE FLUID LEVELS IN TISSUE

• US 20070276327A1
• Filed: 05/23/2006
• Published: 11/29/2007
• Est. Priority Date: 05/23/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Kalafut, John, Ezekiel, Guy
• Granted Patent: US 7,674,244 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

A system for injection of a fluid into a body includes: a source of a first fluid, a source of a second fluid; the first fluid being less toxic than the second fluid; at least one pressurizing system in operative connection with the source of the first fluid and with the source of the second fluid; at least one controller in operative connection with the pressurizing system; and at least a first sensor in communicative connection with the controller. The first sensor is adapted to transmit a signal of a detected change in fluid level in tissue indicative of extravasation to the controller. The controller is adapted to cause injection of the first fluid into the body to determine if extravasation of the first fluid occurs using the sensor in an administration phase before injection of the second fluid.

Claims

1. A system for injection of a fluid into a body, comprising:

a source of a first fluid,

a source of a second fluid;

the first fluid being less toxic than the second fluid

at least one pressurizing system in operative connection with the source of the first fluid and with the source of the second fluid;

at least one controller in operative connection with the pressurizing system; and

at least a first sensor in communicative connection with the controller, the first sensor being adapted to transmit a signal of a detected change in fluid level in tissue indicative of extravasation to the controller, the controller being adapted to cause injection of the first fluid into the body to determine if extravasation of the first fluid occurs using the sensor in an administration phase before injection of the second fluid.

2. The system of claim 1 wherein the controller injects the first fluid into the body in a manner to approximate at least one parameter of at least one phase of injection of the second fluid programmed in the controller.

3. The system of claim 2 wherein the flow rate of the first fluid is varied during the administration phase.

4. The system of claim 1 wherein the first fluid includes saline.

5. The system of claim 1 wherein the second fluid includes a contrast medium for use in connection with an imaging procedure.

6. The system of claim 1 wherein the second fluid includes a therapeutic agent.

7. The system of claim 1 wherein the pressurizing system comprises an injector comprising at least a first drive member and a second drive member.

8. The system of claim 6 wherein the source of the first fluid is a first syringe having a plunger slidably disposed therein and the source of the second fluid is a second syringe having a plunger slidably disposed therein, the injector comprising a first interface adapted to attach the first syringe thereto and a second interface adapted to attach the second syringe thereto, the first drive member being adapted to cooperate with the plunger of the first syringe and the second drive member being adapted to cooperate with the plunger of the second syringe.

9. The system of claim 1 wherein the first sensor comprises at least one transmitting antenna and at least one receiving antenna, the transmitting antenna being adapted to transmit electromagnetic energy in the frequency range of approximately 300 MHz to approximately 30 GHz into a first volume of the body and the receiving antenna being adapted to receive a resultant signal.

10. The system of claim 9 wherein the resultant signal is proportional to permittivity changes in the first volume of the body.

11. The system of claim 1 further comprising at least a second sensor in communicative connection with the controller, the second sensor being adapted to transmit a signal of a detected change in fluid level in tissue indicative of extravasation to the controller, the second sensor operating in a different manner than the first sensor.

12. A method of injecting a fluid into a body, comprising:

providing a source of a first fluid;

providing a source of a second fluid, the first fluid being less toxic than the second fluid;

providing at least one pressurizing system in operative connection with the source of the first fluid and with the source of the second fluid;

providing at least one controller in operative connection with the pressurizing system;

placing at least a first sensor in operative connection with the body;

placing the first sensor in communicative connection with the controller, the first sensor being adapted to transmit a signal of detected changes in tissue fluid level indicative of extravasation to the controller;

injecting the first fluid into the body in an administration phase;

determining if an extravasation of the first fluid occurs using the first sensor during the administration phase; and

communicating any extravasation detected by the first sensor to the controller.

13. The method of claim 12 further comprising the step of injecting the second fluid into the body if no extravasation is detected by the first sensor during injection of the first fluid in the administration phase.

14. The method of claim 13 wherein the controller injects the first fluid into the body in a manner to approximate at least one parameter of at least one phase of injection of the second fluid programmed in the controller.

15. The method of claim 14 wherein the flow rate of the first fluid is varied during the administration phase.

16. The method of claim 12 wherein the first fluid includes saline.

17. The method of claim 12 wherein the second fluid includes a contrast medium for use in connection with an imaging procedure.

18. The method of claim 12 wherein the second fluid includes a therapeutic agent.

19. The method of claim 12 wherein the pressurizing system comprises an injector comprising at least a first drive member and a second drive member.

20. The method of claim 19 wherein the source of the first fluid is a first syringe having a plunger slidably disposed therein and the source of the second fluid is a second syringe having a plunger slidably disposed therein, the injector comprising a first interface adapted to attach the first syringe thereto and a second interface adapted to attach the second syringe thereto, the first drive member being adapted to cooperate with the plunger of the first syringe and the second drive member being adapted to cooperate with the plunger of the second syringe.

21. The method of claim 12 wherein the first sensor comprises at least one transmitting antenna and at least one receiving antenna, the transmitting antenna being adapted to transmit electromagnetic energy in the frequency range of approximately 300 MHz to approximately 30 GHz into a first volume of the body and the receiving antenna being adapted to receive a resultant signal.

22. The method of claim 21 wherein the resultant signal is proportional to permittivity changes in the first volume of the body.

23. The method of claim 12 further comprising the steps of placing at least a second sensor in operative connection with the body and placing the second sensor in communicative connection with the controller, the second sensor being adapted to transmit a signal of a detected change in fluid level in tissue indicative of extravasation to the controller, the second sensor operating in a different manner than the first sensor.

24. The method of claim 12 further comprising the step of reestablishing an injection site in the body if extravasation is detected in the administration phase.