APPARATUS AND DISPLAY METHODS RELATING TO INTRAVASCULAR PLACEMENT OF A CATHETER

• US 20100036227A1
• Filed: 09/10/2009
• Published: 02/11/2010
• Est. Priority Date: 11/26/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Crook, Christian W., Morris, Daniel R., Cox, Jeremy B., Misener, Anthony K., Morgan, Paul D.
• Granted Patent: US 8,849,382 B2
• Time in Patent Office: Days
• US Class Current: 600/374
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 46/00 Surgical drapes
• 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 5/283 Invasive
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment

Abstract

An integrated catheter placement system for accurately placing a catheter within a patient'"'"'s vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient'"'"'s chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient'"'"'s heart. Various aspects for visualizing and manipulating display of the ECG signal data acquired via the present system, together with aspects of various ECG sensor configurations, are also disclosed.

Claims

1. A catheter placement system for inserting a catheter into a vasculature of a patient, comprising:

a catheter assembly including;

an ECG sensor component for detecting ECG signals of a node of a heart of the patient when at least a portion of the catheter assembly is disposed within the vasculature of the patient;

an ECG signal receiving component that receives ECG signals detected by the ECG sensor component, the ECG signal receiving component being operably connectable to the ECG sensor component; and

a connection integrity component that indicates an operable connection between the ECG signal receiving component and the ECG sensor component.

2. The catheter placement system as defined in claim 1, wherein the ECG sensor component of the catheter assembly includes an electrode included on a stylet removably received within a lumen of a catheter, wherein the ECG sensor component further includes at least one external ECG electrode for placement on a skin portion of the patient, and wherein the ECG signal receiving component is disposed external to the patient.

3. The catheter placement system as defined in claim 2, wherein the at least one external ECG electrode includes a first electrode and a second electrode positioned on a single pad for placement on the skin portion of the patient.

4. The catheter placement system as defined in claim 2, wherein the at least one external ECG electrode includes an image indicating proper placement of the at least one external ECG electrode on the skin portion of the patient.

5. The catheter placement system as defined in claim 1, further comprising a display and an indicator icon included on the display, wherein the indicator icon indicates a status of the operable connection between the ECG signal receiving component and the ECG sensor component.

6. The catheter placement system as defined in claim 1, wherein the ECG signal receiving component is operably connectable to the ECG sensor component via a physical connection therebetween.

7. The catheter placement system as defined in claim 6, wherein the connection integrity component includes at least one of an impedance-based sensing circuit, an inductive sensing circuit, a capacitive sensing circuit, and a voltage-based circuit.

8. The catheter placement system as defined in claim 1, wherein the ECG sensor component of the catheter assembly includes an electrode included on a stylet removably received within a lumen of a catheter, the stylet including an assembly for detecting if the stylet has been severed.

9. The catheter placement system as defined in claim 1, wherein the ECG sensor component of the catheter assembly includes an electrode included on a stylet removably received within a lumen of a catheter, the stylet including a system for ensuring a distal end of the stylet is substantially aligned with a distal end of the catheter.

10. The catheter placement system as defined in claim 1, further comprising a footswitch for controlling an aspect of the catheter placement system functionality during use.

11. The catheter placement system as defined in claim 1, wherein the connection integrity component includes a radiating element for emitting a signal detectable on at least one lead wire of the ECG sensor component.

12. In a catheter placement system including a catheter assembly and an ECG sensor component for detecting ECG signal data of a node of a patient when a catheter of the catheter assembly is at least partially disposed within the patient, a method for displaying the ECG signal data, the method comprising:

sampling the ECG signal data;

identifying an ECG waveform from the sampled ECG signal data;

defining at least one parameter of a display window of the catheter placement system; and

displaying the ECG waveform in the display window according to the at least one parameter of the display window.

13. The method for displaying as defined in claim 12, wherein displaying the ECG waveform further comprises:

combining the ECG waveform with at least one previous ECG waveform when permitted by the at least one parameter of the display window; and

displaying the ECG waveform with the at least one previous ECG waveform in the display window when permitted by the at least one parameter of the display window.

14. The method for displaying as defined in claim 12, wherein defining the at least one parameter further comprises:

defining the at least one parameter of the display window according to at least one of a user-defined control and an autonomous control.

15. The method for displaying as defined in claim 12, wherein the display window is included on a visual display of a console of the catheter placement system.

16. The method for displaying as defined in claim 12, wherein defining the at least one parameter further comprises:

defining the number of ECG waveforms to be included in the display window.

17. The method for displaying as defined in claim 12, wherein defining the at least one parameter further comprises:

defining an amount of time an ECG waveform is to be shown in the display window.

18. In a catheter placement system including a catheter assembly and an ECG sensor component for detecting ECG signal data of a node of a patient when a catheter of the catheter assembly is at least partially disposed within the patient, a method for displaying an ECG waveform, the method comprising:

sampling the ECG signal data;

identifying an ECG waveform from the sampled ECG signal data;

identifying a characteristic relating to the ECG waveform; and

displaying the ECG waveform.

19. The method for displaying as defined in claim 18, wherein identifying the characteristic further comprises:

identifying a P-wave portion of the ECG waveform.

20. The method for displaying as defined in claim 19, wherein identifying the P-wave portion includes comparing a portion of the ECG waveform with a known P-wave template.

21. The method for displaying as defined in claim 18, wherein displaying the ECG waveform further comprises:

visually highlighting the P-wave portion of the ECG waveform when displaying the ECG waveform.

22. The method for displaying as defined in claim 18, further comprising:

identifying a QRS complex of the ECG waveform; and

determining a ratio between a magnitude of the P-wave portion and a magnitude of the QRS complex; and

displaying the ECG waveform with data relating to the ratio.

23. The method for displaying as defined in claim 18, further comprising:

freezing the ECG waveform on a display of the catheter placement system in response to user input.

24. The method for displaying as defined in claim 18, further comprising:

storing data relating to the ECG waveform in a storage location.

25. The method for displaying as defined in claim 18, wherein the method is looped to display successive ECG waveforms.

26. The method for displaying as defined in claim 18, further comprising:

producing audible or visual output in response to a characteristic of the ECG waveform.

27. A computer program product for implementing a method for storing information relating to placement of a catheter of a catheter assembly in a vasculature of a patient using a catheter placement system, the catheter assembly including an ECG sensor component for detecting ECG signal data of a node of a patient when the catheter is at least partially disposed within the patient and a magnetic element that produces a magnetic or electromagnetic field that is detectable by the catheter placement system, the computer program product including one or more computer-readable media having stored thereon computer executable instructions that, when executed by a processor, cause the computer system to perform the following:

sample the ECG signal data;

sample magnetic field data of the magnetic element;

associate the ECG signal data and the magnetic field data to a position of the catheter within the patient; and

store the associated ECG signal data and magnetic field data.