System, device, and method for providing and controlling the supply of a distending media for CT colonography

• US 9,561,335 B2
• Filed: 11/22/2011
• Issued: 02/07/2017
• Est. Priority Date: 11/24/2010
• Status: Active Grant

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Inventors: Barish, Allyson, Cushner, Jeffrey B., Stebbins, Christopher R.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/302,484
• Publication Number:
  US 20120130304A1
• Time in Patent Office: 1,904 Days
• Field of Search: 604/24, 604/506, 604/246
• US Class Current: 1/1
• CPC Class Codes: A61B 6/548 Remote control of the apparatus or devices
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2205/7536 allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas

Abstract

Embodiments of the present invention relate to systems, devices, and methods for delivering distending media to an organ of a patient with a dispensing device for acquiring an image of the organ while distended. In one embodiment, an insufflating device comprises a controller for detecting a pressure level of the distending media within an organ of a patient, wherein the controller is configured to signal an operator to acquire an image of the organ when the pressure level is within a predetermined pressure range for a predetermined period of time. Further, the insufflating device comprises a valve assembly in communication with the controller and in fluid communication between the source of distending media and the organ of the patient, wherein the valve assembly is configured to adjust a flow rate of the distending media delivered to the organ of the patient.

Claims

1. An insufflating system adapted to be in fluid communication with a source of a distending media for delivering the distending media to a patient'"'"'s colon for acquiring an image of the colon while distended, the insufflating system comprising:

an insufflating device comprising;

a controller configured for detecting a plurality of different preset pressure levels of the distending media within the colon of the patient; and

a valve assembly in communication with the controller and in fluid communication between the source of distending media and the colon of the patient, wherein the valve assembly is configured to adjust a flow rate of the distending media flowing out of the insufflating device and delivered to the colon of the patient in response to a signal provided by the controller,

wherein the controller is configured to close the valve assembly of the insufflating device to pause further delivery of the distending media from the insufflating device to the colon in response to detecting any one of the preset pressure levels of the distending media delivered to the colon, thereby allowing an operator to check a distention of the patient'"'"'s colon, and

wherein the controller is further configured to open the valve assembly of the insufflating device to resume delivery of the distending media from the insufflating device to the colon in response to a selection from the operator, except when a final target insufflation pressure level is detected, such that a maximum volume of distending media in a distended portion of the colon for safety or comfort of the patient is not exceeded; and

wherein the controller is further configured such that, after first detecting the final target insufflation pressure level, the controller controls the valve assembly to regulate a flow of the distending media and thereby maintains a pressure of the distending media within the colon of the patient within a range of +/−

10% with respect to the final target insufflation pressure level.

2. The insufflating system according to claim 1, further comprising a user interface in communication with the controller and configured to signal the operator of the insufflating system that proper insufflation has been achieved for acquiring an image of the colon of the patient.

3. The insufflating system according to claim 1, wherein the controller is configured to provide an indication that proper distension has been achieved for acquiring an image of the colon of the patient using computer tomography.

4. The insufflating system according to claim 1, wherein the controller is configured to, after detecting the final target insufflation pressure level, monitor a pressure level of the distending media within the colon of the patient and to provide an indication that proper distension has been achieved for acquiring an image of the colon based on the monitored pressure level being within a predetermined pressure range for a predetermined period of time.

5. The insufflating system according to claim 4, wherein the controller is further configured to detect at least one predetermined volume level of the distending media delivered to the colon, and wherein the controller is configured to provide an indication that proper distension has been achieved for acquiring an image of the colon of the patient based on the detected pressure level being within a predetermined pressure range for the predetermined period of time and the at least one detected volume level.

6. The insufflating system according to claim 1, further comprising a relief valve in communication with the controller, wherein the controller is further configured to actuate the relief valve in order to vent the distending media from the colon.

7. The insufflating system according to claim 1, further comprising a wireless remote configured to communicate with the controller for controlling operation thereof.

8. The insufflating system according to claim 1, further comprising a relief valve assembly in communication with the controller, wherein the relief valve assembly is configured to vent the distending media in response to detecting a predetermined pressure threshold for a predetermined period of time.

9. The insufflating system according to claim 1, wherein the controller is further configured to detect at least one predetermined volume level of the distending media within the colon of the patient.

10. The insufflating system according to claim 9, wherein the controller is configured to close the valve assembly to pause further delivery of the distending media in response to detecting a first predetermined volume level of the distending media delivered to the colon.

11. The insufflating system according to claim 10, wherein the controller is further configured to open the valve assembly to resume delivery of the distending media in response to a selection and close the valve assembly in response to detecting a second predetermined volume level.

12. The insufflating system according to claim 1, wherein the valve assembly is further configured to provide a first flow rate while a first volume of distending media is delivered, a second flow rate while a second volume of distending media is delivered, and a third flow rate after the second volume of distending media is delivered.

13. The insufflating system according to claim 1, further comprising an administration set configured to be in fluid communication with the insufflating device and to direct the distending media from the valve assembly to the colon of the patient.

14. The insufflating system according to claim 13, wherein the administration set comprises a security assembly configured to facilitate a connection between the administration set and the insufflating device.

15. The insufflating system according to claim 14, wherein the security assembly is configured to allow a connection between the administration set and the insufflating device when the security assembly detects that the administration set has not been previously used or that the security assembly is compatible with the insufflating device.

16. The insufflating system according to claim 1, wherein the selection from the operator comprises selection of a button on a user interface configured to resume flow of the distending media.

17. A method for delivering distending media to a patient'"'"'s colon with a dispensing device for acquiring an image of the colon while distended, the method comprising:

delivering, via a controller of an insufflating device, the distending media from the insufflating device to the colon of the patient;

pausing, via the controller, delivery of the distending media from the insufflating device in response to detecting a first preset pressure level of the distending media delivered to the colon in order to allow an operator of an insufflating system comprising the insufflating device to check a status of the patient;

resuming, via the controller, delivery of the distending media from the insufflating device to the colon in response to a selection by the operator;

ceasing, via the controller, delivery of the distending media from the insufflating device to the colon in response to detecting a final target insufflation pressure level, wherein the final target insufflation pressure level is different than the first preset pressure level, such that a maximum volume of distending media in a distended portion of the colon for safety or comfort of the patient is not exceeded; and

regulating, via the controller, a flow of the distending media and thereby maintaining a pressure of the distending media within the colon of the patient within a range of +/−

10% with respect to the final target insufflation pressure level after first detecting the final target insufflation pressure level.

18. The method according to claim 17, further comprising:

detecting a pressure level of the distending media within the colon of the patient; and

providing an indication that proper distension has been achieved for acquiring an image of the colon of the patient based at least on the pressure level being within a predetermined pressure range for a predetermined period of time.

19. The method according to claim 18, further comprising detecting at least one predetermined volume level of the distending media delivered to the colon, wherein the providing step comprises providing an indication that proper distension has been achieved for acquiring an image of the colon of the patient based on the pressure level being within the predetermined pressure range for the predetermined period of time and the at least one detected volume level.

20. The method according to claim 17, wherein the selection from the operator comprises selection of a button on a user interface configured to resume flow of the distending media.

21. A method for delivering distending media to a patient'"'"'s colon with a dispensing device for acquiring an image of the colon while distended, the method comprising:

delivering, via a controller of an insufflating device, the distending media from the insufflating device to the colon of the patient;

pausing, via the controller, delivery of the distending media from the insufflating device in response to detecting a first preset pressure level of the distending media delivered to the colon in order to allow an operator of an insufflating system comprising the insufflating device to check a status of the patient;

resuming, via the controller, delivery of the distending media from the insufflating device to the colon in response to a selection by the operator;

ceasing, via the controller, delivery of the distending media from the insufflating device to the colon in response to detecting a second preset pressure level, wherein the second preset pressure level is different than the first preset pressure level;

after detecting a final target insufflation pressure level, monitoring, via the controller, a pressure level of the distending media within the colon of the patient and providing an indication that proper distension has been achieved for acquiring an image of the colon based on the monitored pressure level being within a predetermined pressure range for a predetermined period of time; and

regulating, via the controller, a flow of the distending media and thereby maintaining the pressure level of the distending media within the colon of the patient within a range of +/−

10% with respect to the final target insufflation pressure level after first detecting the final target insufflation pressure level.

22. The method according to claim 21, wherein the selection from the operator comprises selection of a button on a user interface configured to resume flow of the distending media.