Devices, systems and methods for detecting increase fluid levels in tissue

• US 7,674,244 B2
• Filed: 05/23/2006
• Issued: 03/09/2010
• Est. Priority Date: 05/23/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Ezekiel, Guy, Kalafut, John
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): MOULTON, ELIZABETH ROSE
• Application Number:
  US11/419,821
• Publication Number:
  US 20070276327A1
• Time in Patent Office: 1,386 Days
• Field of Search: 600/431, 600/432, 604/65, 604/67, 604/151, 604/131, 604/155
• US Class Current: 604/151
• 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, wherein the first sensor is based on electromagnetic energy and to measure extravasation of the first fluid in at least a first volume of the tissue,

wherein the at least one controller includes an extravasation protocol associated therewith, the extravasation protocol comprising a first protocol wherein at least one of operation of the first sensor or application of a detection model is set to measure extravasation of the first fluid in the administration phase during injection of the first fluid and a second protocol wherein at least one of operation of the first sensor or application of the detection model is set to measure extravasation of the second fluid during subsequent injection of the second fluid,

wherein settings in the first protocol are different than settings in the second protocol.

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 a 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 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, a first drive member of the pressurizing mechanism being adapted to cooperate with the plunger of the first syringe and a second drive member of the pressurizing mechanism being adapted to cooperate with the plunger of the second syringe.

8. 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 the first volume of the body in the first protocol and the second protocol and the receiving antenna being adapted to receive a resultant signal.

9. The system of claim 8 wherein the first protocol and the second protocol are substantially the same and the resultant signal is proportional to permittivity changes in the first volume of the body.

10. 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.

11. The system of claim 1 wherein the extravasation protocol further includes at least one learning algorithm.

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;

associating an extravasation protocol with the controller, the extravasation protocol comprising a first protocol wherein at least one of operation of the first sensor or application of a detection model is set to measure extravasation of the first fluid in an administration phase during injection of the first fluid and a second protocol wherein of at least one of operation of the first sensor or application of the detection model is set to measure extravasation of the second fluid during subsequent injection of the second fluid;

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

injecting the first fluid into the body in the administration phase while operating the first sensor according to settings of the first protocol;

obtaining at least one signal from the first sensor during the administration phase;

determining if an extravasation of the first fluid occurs using the at least one signal from the first sensor during the administration phase and the detection model as set by the first protocol,

communicating any extravasation detected by the detection model to the controllers;

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, while operating the first sensor according to the settings of the second protocol;

obtaining at least one signal from the first sensor during the injection of the second fluid;

determining if an extravasation of the second fluid occurs using the at least one signal from the first sensor during injection of the second fluid and the detection model as set by second first protocol, and

communicating any extravasation detected by the detection model to the controller,

wherein settings in the first protocol are different than settings in the second protocol.

13. The method of claim 12 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.

14. The method of claim 13 wherein the flow rate of the first fluid is varied during the administration phase.

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

16. The method of claim 12 wherein the second fluid includes at least one of a contrast medium for use in connection with an imaging procedure or a therapeutic agent.

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

18. The method of claim 17 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.

19. 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 in the first protocol and the second protocol and the receiving antenna being adapted to receive a resultant signal.

20. The method of claim 19 wherein the first protocol and the second protocol are substantially the same and the resultant signal is proportional to permittivity changes in the first volume of the body.

21. 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.

22. 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.

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

a source of a first fluid;

a source of a second fluid, wherein the first fluid is different 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;

at least a first sensor in communicative connection with the controller,

wherein the first sensor is adapted to transmit a signal of a detected change in fluid level in tissue indicative of extravasation to the controller,

wherein the controller is adapted to cause injection of at least the first fluid into the body to determine if extravasation of at least the first fluid occurs using the sensor in an administration phase before injection of at least the second fluid,

wherein the first sensor is based on electromagnetic energy and measures extravasation of the at least first fluid in at least a first volume of the tissue,

wherein the at least one controller includes an extravasation protocol associated therewith,

wherein the extravasation protocol comprises a first protocol having at least one of operation of the first sensor or application of a detection model is set to measure extravasation of the at least first fluid in the administration phase during injection of the at least first fluid, and

a second protocol having at least one of operation of the first sensor or application of the detection model is set to measure extravasation of the at least second fluid during subsequent injection of the at least second fluid, wherein the first protocol and second protocol are different.