Medical injection system

• US 9,901,671 B2
• Filed: 11/05/2007
• Issued: 02/27/2018
• Est. Priority Date: 05/30/2001
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Toews, Glenn, Szczech, Chris, McPeak, Thomas J., Duchon, Douglas J.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US11/935,021
• Publication Number:
  US 20090076383A1
• Time in Patent Office: 3,767 Days
• Field of Search: 604131, 604151, 604500, 604 65, 600547, 600431-435
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/007 for contrast media
• 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 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod

Abstract

A method of preventing extravaation of contrast agent during a computed tomography injection. An automatic injector device facilitates ease of accomplishing the method. The method includes establishing the absence of extravaation using an absorbable injectate, such as saline, prior to injecting the contrast agent. The device includes a computerized injector head capable of switching between two injectates without physical human intervention. The device is controlled by a remote operating panel located in a control room that is protected from X-ray radiation. The device includes various software driven safety features that prevent the occurrence of unsafe conditions.

Claims

1. A method of injecting a contrast agent into a vessel of a patient, the method comprising:

using a percutaneous implement defining a lumen and having a distal end;

attempting to position the distal end of the implement in a vessel of a patient such that fluid communication is established between the lumen and the vessel;

instructing an automatic injection device to inject a predetermined amount of a first fluid at a first flow rate from a first syringe into the lumen such that the first fluid exits the distal end of the implement, the first fluid comprising saline, wherein the first flow rate is selected to be substantially equal to a desired flow rate of a contrast agent that is to be injected by the automatic injection device from a second syringe after injection of the predetermined amount of the first fluid from the first syringe, wherein the first syringe is connected to a fluid communication network using a first tube, wherein the second syringe is connected to the fluid communication network using a second tube different from the first tube, wherein the fluid communication network is further connected to the lumen, wherein the fluid communication network includes a valve that is configured to selectively provide the first fluid at the first flow rate from the first syringe, through the first tube and to the lumen, while blocking any fluid flow of the contrast agent from the second syringe to the lumen, and wherein responsive to at least one processor of the automatic injection device determining that a flow rate of the first fluid exceeds the first flow rate, the at least one processor is configured to shut down the automatic injection device by disabling power to a motor of the automatic injection device;

while the automatic injection device is injecting the predetermined amount of the first fluid at the first flow rate from the first syringe into the lumen, determining whether fluid communication is established between the lumen and the vessel based on flow of the first fluid;

upon determining that fluid communication is not established between the lumen and the vessel, repeatedly performing the following actions until it is determined that fluid communication is established between the lumen and the vessel;

pausing operation of the automatic injection device;

attempting to reposition the distal end of the implement in the vessel of the patient;

resuming operation of the automatic injection device upon repositioning of the distal end of the implement; and

instructing the automatic injection device to inject the predetermined amount of the first fluid at the first flow rate from the first syringe into the lumen such that the first fluid exits the distal end of the implement; and

after fluid communication is established between the lumen and the vessel based on flow of the first fluid, instructing the automatic injection device to inject a predetermined amount of the contrast agent from the second syringe into the lumen at a second flow rate that is substantially equal to the first flow rate of the first fluid, wherein the valve of the fluid communication network is configured to selectively provide the contrast agent at the second flow rate from the second syringe, through the second tube and to the lumen, while blocking any fluid flow of the first fluid from the first syringe to the lumen,

wherein the at least one processor of the automatic injection device is configured to maintain the second flow rate of the contrast agent within a predetermined range such that the second flow rate of the contrast agent does not exceed the first flow rate of the first fluid, and wherein responsive to the at least one processor determining that the second flow rate of the contrast agent exceeds the first flow rate, the at least one processor is configured to shut down the automatic injection device by disabling power to the motor of the automatic injection device.

2. The method of claim 1, further comprising:

instructing the automatic injection device to inject an additional amount of the first fluid into the vessel through the lumen after injecting the predetermined amount of the contrast agent.

3. The method of claim 1, wherein determining whether fluid communication is established between the lumen and the vessel comprises feeling an area of the patient proximate the distal end of the implement for an occurrence of extravasation.

4. The method of claim 1, wherein the at least one processor of the automatic injection device is configured to maintain the second flow rate of the contrast agent within the predetermined range such that the second flow rate of the contrast agent does not exceed the first flow rate of the first fluid by comparing data representing a speed of the motor with data representing a limit on the speed of the motor, the data representing the speed of the motor being associated with the second flow rate of the contrast agent, and the data representing the limit on the speed of the motor being associated with the first flow rate of first fluid.

5. A method of injecting a contrast agent into a vessel using an automatic injection device, the method comprising:

operably connecting the device to a patient;

using a percutaneous implement defining a lumen and having a distal end;

positioning the distal end of the implement in the vessel;

determining whether fluid communication is established between the lumen and the vessel at a given test flow rate of saline while the saline is injected from a first syringe of the device, wherein the test flow rate is selected to be substantially equal to a desired flow rate of a contrast agent that is to be injected from a second syringe of the device after injection of the saline from the first syringe, wherein the first syringe is connected to a fluid communication network using a first tube, wherein the second syringe is connected to the fluid communication network using a second tube different from the first tube, wherein the fluid communication network is further connected to the lumen, wherein the fluid communication network includes a valve that is configured to selectively provide the saline at the test flow rate from the first syringe, through the first tube and to the lumen, while blocking any fluid flow of the contrast agent from the second syringe to the lumen, and wherein responsive to at least one processor of the automatic injection device determining that a flow rate of the saline exceeds the test flow rate, the at least one processor is configured to shut down the automatic injection device; and

after the fluid communication is established between the lumen and the vessel based on flow of the saline;

programming the device to inject a predetermined amount of the contrast agent from the second syringe into the lumen at a flow rate that is substantially equal to the test flow rate, wherein the valve of the fluid communication network is configured to selectively provide the contrast agent at the flow rate from the second syringe, through the second tube and to the lumen, while blocking any fluid flow of the saline from the first syringe to the lumen,

wherein the at least one processor of the automatic injection device is configured to maintain the flow rate of the contrast agent within a predetermined range such that the flow rate of the contrast agent does not exceed the test flow rate of the saline, and wherein responsive to the at least one processor determining that the flow rate of the contrast agent exceeds the test flow rate, the at least one processor is configured to shut down the automatic injection device.

6. The method of claim 5, wherein the at least one processor of the automatic injection device is configured to maintain the flow rate of the contrast agent within the predetermined range such that the flow rate of the contrast agent does not exceed the test flow rate of the saline by comparing data representing a speed of the motor with data representing a limit on the speed of the motor, the data representing the speed of the motor being associated with the flow rate of the contrast agent, and the data representing the limit on the speed of the motor being associated with the test flow rate of saline, and wherein the method further comprises programming the device to inject a predetermined amount of a flushing fluid into the vessel of the patient via the lumen after the contrast agent has been injected.

7. The method of claim 6, wherein a flow rate of the flushing fluid injection is substantially based on equal to the test flow rate.

8. A method of establishing an absence of extravasation prior to injecting a contrast agent, the method comprising:

using a percutaneous implement defining a lumen and having a distal end;

positioning the distal end of the percutaneous implement in a vessel to establish fluid communication between the lumen and the vessel;

causing an automatic injector to deliver a preliminary injection of a first fluid from a first syringe into the lumen at a preliminary injection flow rate such that the first fluid exits the distal end of the percutaneous implement, the first fluid comprising saline, wherein the preliminary injection flow rate is selected to be substantially equal to a desired flow rate of a contrast agent that is to be injected by the automatic injector from a second syringe after the preliminary injection of the first fluid from the first syringe, wherein the first syringe is connected to a fluid communication network using a first tube, wherein the second syringe is connected to the fluid communication network using a second tube different from the first tube, wherein the fluid communication network is further connected to the lumen, wherein the fluid communication network includes a valve that is configured to selectively provide the first fluid at the preliminary injection flow rate from the first syringe, through the first tube and to the lumen, while blocking any fluid flow of the contrast agent from the second syringe to the lumen, and wherein responsive to at least one processor of the automatic injector determining that a flow rate of the first fluid exceeds the preliminary injection flow rate, the at least one processor is configured to shut down the automatic injection device by disabling power to a motor of the automatic injector;

while the automatic injector is injecting the first fluid at the preliminary injection flow rate from the first syringe into the lumen, determining whether fluid communication is established between the lumen and the vessel based on flow of the first fluid;

if fluid communication is established;

causing the automatic injector to inject a predetermined amount of the contrast agent from the second syringe into the lumen at a predetermined flow rate that is substantially equal to the preliminary injection flow rate of the first fluid, wherein the valve of the fluid communication network is configured to selectively provide the contrast agent at the predetermined flow rate from the second syringe, through the second tube and to the lumen, while blocking any fluid flow of the first fluid from the first syringe to the lumen,

wherein the at least one processor of the automatic injector is configured to maintain the predetermined flow rate of the contrast agent within a predetermined range such that the predetermined flow rate does not exceed the preliminary injection flow rate of the first fluid;

if fluid communication is not established;

stopping the preliminary injection;

repeating positioning the distal end of the percutaneous implement in the vessel, causing the automatic injector to deliver the preliminary injection from the first syringe at the preliminary injection flow rate, determining whether fluid communication is established between the lumen and the vessel based on flow of the first fluid, and stopping the preliminary injection, until fluid communication is established between the lumen and the vessel; and

after fluid communication is established between the lumen and the vessel based on flow of the first fluid, causing the automatic injector to inject the predetermined amount of contrast agent from the second syringe into the lumen at the predetermined flow rate that is substantially equal to the preliminary injection flow rate of the first fluid,

wherein responsive to the at least one processor determining that the predetermined flow rate of the contrast agent exceeds the preliminary injection flow rate, the at least one processor is configured to shut down the automatic injector by disabling power to the motor of the automatic injector.

9. The method of claim 8, wherein the preliminary injection has an unspecified duration.

10. The method of claim 8, wherein the preliminary injection has a user determined duration.

11. The method of claim 8, wherein the at least one processor of the automatic injector is configured to maintain the predetermined flow rate of the contrast agent within the predetermined range such that the predetermined flow rate does not exceed the preliminary injection flow rate of the first fluid by comparing data representing a speed of the motor with data representing a limit on the speed of the motor, the data representing the speed of the motor being associated with the predetermined flow rate of the contrast agent, and the data representing the limit on the speed of the motor being associated with the preliminary injection flow rate of first fluid.