Method of locating the tip of a central venous catheter

• US 9,345,422 B2
• Filed: 10/03/2014
• Issued: 05/24/2016
• 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:
  US14/506,552
• Publication Number:
  US 20150025402A1
• Time in Patent Office: 599 Days
• US Class Current: 1/1
• 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 method of locating a tip of a central venous catheter based on a reference P wave detected by a reference pair of electrodes, a first P wave detected by a first pair of electrodes disposed near the tip of the central venous catheter, and a second P wave detected by a second pair of electrodes disposed on the central venous catheter and spaced proximally from the first pair, the method comprising:

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

determining 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;

comparing the first deflection value to the second deflection value;

comparing the reference P wave with at least one of the first and second P waves; and

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

2. The method according to 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 determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the first ratio to a predetermined maximum threshold.

3. The method according to 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 determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the first ratio to a predetermined minimum threshold.

4. The method according to claim 1, 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, and wherein determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the second ratio to a predetermined maximum threshold.

5. The method according to claim 1, wherein the first, second, and reference P waves each comprise a series of discrete numerical values, and wherein calculating the first, second and reference deflection values as a function of the first, second, and reference P waves comprise:

determining a maximum value within the series of discrete numerical values of the P wave;

determining a minimum value within the series of discrete numerical values of the P wave;

determining a polarity of the maximum value and a polarity of the minimum value;

comparing the polarity of the maximum value to the polarity of the minimum value;

determining a larger of an absolute value of the maximum value and an absolute value of the minimum value; and

totaling the absolute values of the maximum and minimum values.

6. The method according to 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:

without advancing or withdrawing the tip of the central venous catheter, either determining that the tip of the central venous catheter is located in a desired location when the first ratio and the second ratio are both approximately one, or that the tip of the central venous catheter has been inserted too far when the second ratio is greater than a maximum predefined threshold value, when the first ratio is greater than the maximum predefined threshold value, or when the first ratio is less than a minimum predefined threshold value.