Method of locating the tip of a central venous catheter

• US 9,833,169 B2
• Filed: 05/20/2016
• Issued: 12/05/2017
• Est. Priority Date: 10/23/2006
• Status: Active Grant

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Rothenberg, Peter M.
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US15/160,958
• Publication Number:
  US 20160262656A1
• Time in Patent Office: 564 Days
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/353 Detecting P-waves
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

A method of locating a tip of a central venous catheter (“CVC”) having a distal and proximal pair of electrodes disposed within the superior vena cava, right atrium, and/or right ventricle. The method includes obtaining a distal and proximal electrical signal from the distal and proximal pair of electrodes and using those signals to generate a distal and proximal P wave, respectively. A deflection value is determined for each of the P waves. A ratio of the deflection values is then used to determine a location of the tip of the CVC. Optionally, the CVC may include a reference pair of electrodes disposed within the superior vena cava from which a reference deflection value may be obtained. A ratio of one of the other deflection values to the reference deflection value may be used to determine the location of the tip of the CVC.

Claims

1. A non-transitory, computer-readable storage medium having stored thereon logic for determining a location of a tip of a central venous catheter based on a reference P wave detected by a reference pair of electrodes, the logic, that upon execution by one or more processors, performs operations comprising:

detecting a reference P wave by the reference pair of electrodes;

detecting a first P wave by a first pair of electrodes disposed near the tip of the central venous catheter;

detecting a second P wave by a second pair of electrodes disposed on the central venous catheter and spaced proximally from the first pair of electrodes;

calculating a first deflection value as a function of the first P wave;

calculating a second deflection value as a function of the second P wave;

calculating a reference deflection value as a function of the reference P wave;

determining a location of the tip of the central venous catheter based on a comparison of the first and second deflection values and a comparison of the reference P wave with at least one of the first and second P waves; and

generating a display image providing real-time feedback of the location of the tip of the central venous catheter, the display image configured to be displayed on a display device, wherein the display image of the real-time feedback includes (i) an image of a lumen or an organ, and (ii) a visual representation of an estimated location of the tip of the central venous catheter, wherein the display image of the real-time feedback further includes an indicator configured to provide guidance as to whether the central venous catheter is to be withdrawn or advanced based on one or more of (i) the comparison of the first and second deflection values or (ii) the comparison of the reference P wave with at least one of the first and second P waves.

2. The storage medium of claim 1, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a first ratio of the first deflection value to the second deflection value;

comparing the first ratio to a predetermined maximum threshold; and

responsive to the first ratio equaling or exceeding the predetermined maximum threshold, providing an alert that the tip of the central venous catheter is located in a right atrium.

3. The storage medium of claim 1, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a first ratio of the first deflection value to the second deflection value;

comparing the first ratio to a predetermined minimum threshold; and

responsive to the first ratio being equal to or less than the predetermined minimum threshold, providing an alert that the tip of the central venous catheter is located in a right ventricle.

4. The storage medium of claim 1, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a second ratio of one of the first and second deflection values to the reference deflection value;

comparing the second ratio to a predetermined maximum threshold; and

responsive to the second ratio equaling or exceeding the predetermined maximum threshold, providing an alert, the alert indicating the tip of the central venous catheter is to be withdrawn.

5. The storage medium of claim 1, wherein the first, second, and reference P waves each comprise a series of discrete numerical values, and wherein the logic, upon execution by the one or more processors, performs operations further comprising:

determining a maximum value within the series of discrete numerical values of the first P wave, the second P wave and the reference P wave;

determining a minimum value within the series of discrete numerical values of the first P wave, the second P wave and the reference P wave;

determining a larger of an absolute value of the maximum value and an absolute value of the minimum value of each of the first P wave, the second P wave and the reference P wave; and

totaling the absolute values of the maximum and minimum values of each of the first P wave, the second P wave and the reference P wave.

6. The storage medium of claim 1, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating the first deflection value as a function of the first P wave by determining an absolute value of a larger of a maximum value of the first P wave and a minimum value of the first P wave when the maximum value of the first P wave and the minimum value of the first P wave have a same first polarity;

calculating the second deflection value as a function of the second P wave by determining an absolute value of a larger of a maximum value of the second P wave and a minimum value of the second P wave when the maximum value of the second P wave and the minimum value of the second P wave have a same second polarity; and

calculating the reference deflection value as a function of the reference P wave by determining an absolute value of a larger of a maximum value of the reference P wave and a minimum value of the reference P wave when the maximum value of the reference P wave and the minimum value of the reference P wave have a same third polarity.

7. The storage medium of claim 1, wherein comparing the first deflection value to the second deflection value comprises calculating a first ratio of the first deflection value to the second deflection value, and wherein comparing the reference P wave with at least one of the first and second P waves comprises calculating a second ratio of one of the first and second deflection values to the reference deflection value, further comprising determining a position of the tip of the central venous catheter without the tip of the central venous catheter being advanced or withdrawn, the determined position being:

located in a desired location when the first ratio and the second ratio are both approximately one, or located in an undesired location when;

the second ratio is greater than or equal to a maximum predefined threshold value, the first ratio is greater than or equal to the maximum predefined threshold value, or the first ratio is less than or equal to a minimum predefined threshold value.

8. A system for determining a location of a tip of a central venous catheter, the system comprising:

a first pair of electrodes disposed near the tip of the central venous catheter for detecting a first P wave;

a second pair of electrodes disposed on the central venous catheter and spaced proximally from the first pair of electrodes, the second pair of electrodes for detecting a second P wave;

a reference pair of electrodes for a reference P wave disposed on the central venous catheter and spaced proximal from the first pair of electrodes and the second pair of electrodes;

one or more processors communicatively coupled to the reference pair of electrodes, the first pair of electrodes and the second pair of electrodes;

a display device communicatively coupled to the one or more processors; and

a storage module communicatively coupled to the one or more processors, the storage module comprising logic, that when executed by the one or more processors, causes performance of operations comprising;

calculating a first deflection value as a function of the first P wave;

calculating a second deflection value as a function of the second P wave;

calculating a reference deflection value as a function of the reference P wave;

determining the location of the tip of the central venous catheter based on a comparison of the first deflection value and the second deflection value and a comparison of the reference P wave with at least one of the first P wave and the second P wave; and

providing a display of real-time feedback of the location of the tip of the central venous catheter with the display device, wherein the display of the real-time feedback includes (i) an image of a lumen or an organ, and (ii) a visual representation of the location of the tip of the central venous catheter, wherein the display of the real-time feedback further includes an indicator configured to provide guidance as to whether the central venous catheter is to be withdrawn or advanced based on one or more of (i) the comparison of the first deflection value and the second deflection value or (ii) the comparison of the reference P wave with at least one of the first P wave and the second P wave.

9. The system of claim 8, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a first ratio of the first deflection value to the second deflection value;

comparing the first ratio to a predetermined maximum threshold; and

responsive to the first ratio equaling or exceeding the predetermined maximum threshold, providing an alert that the tip of the central venous catheter is located in a right atrium.

10. The system of claim 8, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a first ratio of the first deflection value to the second deflection value;

comparing the first ratio to a predetermined minimum threshold; and

responsive to the first ratio being equal to or less than the predetermined minimum threshold, providing an alert that the tip of the central venous catheter is located in a right ventricle.

11. The system of claim 8, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating a second ratio of one of the first deflection value and the second deflection value to the reference deflection value;

comparing the second ratio to a predetermined maximum threshold; and

responsive to the second ratio equaling or exceeding the predetermined maximum threshold, providing an alert, the alert indicating the tip of the central venous catheter is to be withdrawn.

12. The system of claim 8, wherein the first P wave, the second P wave, and the reference P wave each comprise a series of discrete numerical values, and wherein the logic, upon execution by the one or more processors, performs operations further comprising:

determining a maximum value within the series of discrete numerical values of the first P wave, the second P wave and the reference P wave;

determining a minimum value within the series of discrete numerical values of the first P wave, the second P wave and the reference P wave;

determining a larger value between an absolute value of the maximum value and an absolute value of the minimum value of each of the first P wave, the second P wave and the reference P wave; and

totaling the absolute values of the maximum and minimum values of each of the first P wave, the second P wave and the reference P wave.

13. The system of claim 8, wherein comparing the first deflection value to the second deflection value comprises calculating a first ratio of the first deflection value to the second deflection value, and wherein comparing the reference P wave with at least one of the first P wave and the second P wave comprises calculating a second ratio of one of the first deflection value and the second deflection value to the reference deflection value, further comprising determining a position of the tip of the central venous catheter without the tip of the central venous catheter being advanced or withdrawn, the determined position being:

located in a desired location when the first ratio and the second ratio are both approximately one, or located in an undesired location when;

the second ratio is greater than or equal to a maximum predefined threshold value,

the first ratio is greater than or equal to the maximum predefined threshold value, or

the first ratio is less than or equal to a minimum predefined threshold value.

14. The system of claim 8, wherein the logic, upon execution by the one or more processors, performs operations further comprising:

calculating the first deflection value as the function of the first P wave by determining an absolute value of a larger of a maximum value of the first P wave and a minimum value of the first P wave when the maximum value of the first P wave and the minimum value of the first P wave have a same first polarity;

calculating the second deflection value as the function of the second P wave by determining an absolute value of a larger of a maximum value of the second P wave and a minimum value of the second P wave when the maximum value of the second P wave and the minimum value of the second P wave have a same second polarity; and

calculating the reference deflection value as the function of the reference P wave by determining an absolute value of a larger of a maximum value of the reference P wave and a minimum value of the reference P wave when the maximum value of the reference P wave and the minimum value of the reference P wave have a same third polarity.