Systems and methods for intravascular catheter positioning and/or nerve stimulation

• US 10,195,429 B1
• Filed: 08/02/2017
• Issued: 02/05/2019
• Est. Priority Date: 08/02/2017
• Status: Active Grant

• Current Assignee: Lungpacer Medical Inc.
• Original Assignee: Lungpacer Medical Inc.
• Inventors: Thakkar, Viral S., Evans, Douglas G., Gani, Matthew J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/666,989
• Publication Number:
  US 20190038897A1
• Time in Patent Office: 552 Days
• Field of Search: None
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• 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 5/4893 Nerves
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A method for positioning an intravascular catheter may include inserting the intravascular catheter into a venous system of a patient, wherein the catheter includes a plurality of electrodes, and multiple electrodes of the plurality of electrodes are configured to emit electrical signals; positioning a distal portion of the catheter in a first position; using one or more electrodes of the plurality of electrodes to acquire an ECG signal; based on the acquired ECG signal, adjusting the distal portion of the catheter to a second position different from the first position; identifying at least one first electrode of the plurality of electrodes to stimulate a first nerve; identifying at least one second electrode of the plurality of electrodes to stimulate a second nerve; and stimulating at least one of the first and second nerves to cause a contraction of a respiratory muscle.

Claims

1. A method for positioning an intravascular catheter, comprising:

inserting the intravascular catheter into a venous system of a patient, wherein the catheter includes a plurality of electrodes, and multiple electrodes of the plurality of electrodes are configured to emit electrical signals;

positioning a distal portion of the catheter in a first position;

using one or more electrodes of the plurality of electrodes to acquire a first ECG signal and a second ECG signal;

determining a difference between the first ECG signal and the second ECG signal;

comparing the difference to a value;

based on the comparison of the difference to the value, adjusting the distal portion of the catheter to a second position different from the first position;

identifying at least one first electrode of the plurality of electrodes to stimulate a first nerve;

identifying at least one second electrode of the plurality of electrodes to stimulate a second nerve; and

stimulating at least one of the first and second nerves to cause a contraction of a respiratory muscle.

2. The method of claim 1, wherein inserting the intravascular catheter into the venous system includes inserting the intravascular catheter into:

1) at least one of a left subclavian, axillary, cephalic, cardiophrenic, brachial, radial, or left jugular vein, and

     2) a superior vena cava.

3. The method of claim 1, wherein the first position is proximate an atrium of a heart of the patient, and the second position is in a superior vena cava.

4. The method of claim 1, wherein the first ECG signal is acquired by one or more electrodes that are positioned on a proximal portion of the catheter and are configured to stimulate the first nerve, and the second ECG signal is acquired by one or more electrodes that are positioned on a distal portion of the catheter and are configured to stimulate the second nerve.

5. The method of claim 1, wherein the second position is farther from a heart of the patient than the first position.

6. The method of claim 1, further comprising using one or more electrodes of the plurality of electrodes to sense at least one of an impedance or nerve activity.

7. The method of claim 1, wherein each of the at least one first electrode and the at least one second electrode is a combination of electrodes.

8. A method for positioning an intravascular catheter, comprising:

inserting the intravascular catheter into;

     1) at least one of a left subclavian vein or a left jugular vein, and

     2) a superior vena cava, wherein the catheter includes a plurality of electrodes, and the plurality of electrodes includes a proximal set of electrodes positioned proximate a left phrenic nerve and a distal set of electrodes positioned proximate a right phrenic nerve;

using one or more electrodes of the plurality of electrodes to acquire a first ECG signal and a second ECG signal;

determining a difference between the first ECG signal and the second ECG signal;

comparing the difference to a value;

based on the comparison of the difference to the value, withdrawing the catheter away from a heart of a patient;

stimulating the left phrenic nerve using one or more electrodes of the proximal set of electrodes; and

stimulating the right phrenic nerve using one or more electrodes of the distal set of electrodes.

9. The method of claim 8, wherein the step of withdrawing the catheter away from the heart causes a change in an amplitude of a P-wave of the first ECG signal or the second ECG signal.

10. The method of claim 8, wherein the first ECG signal is acquired by one or more electrodes of the proximal set of electrodes, and the second ECG signal is acquired by one or more electrodes of the distal set of electrodes.

11. The method of claim 8, wherein the difference between the first ECG signal and the second ECG signal is a difference between a P-wave of the first ECG signal and a P-wave of the second ECG signal.

12. The method of claim 8, wherein the difference exceeds the value when the catheter is advanced into an atrium of the heart.

13. The method of claim 8, wherein a hub coupled to the catheter and positioned exterior to the patient is used with the one or more electrodes of the plurality of electrodes to acquire the ECG signal.

14. The method of claim 8, further comprising monitoring the first ECG signal and the second ECG signal as a distal end of the catheter is inserted into the at least one of the left subclavian vein or the left jugular vein and advanced into the superior vena cava.

15. A method for positioning an intravascular catheter, comprising:

inserting the intravascular catheter into a venous system of a patient, wherein the catheter includes a plurality of proximal electrodes and a plurality of distal electrodes;

using one or more electrodes of the plurality of proximal electrodes to acquire a first ECG signal, and using one or more electrodes of the plurality of distal electrodes to acquire a second ECG signal;

determining a difference between the first ECG signal and the second ECG signal;

comparing the difference to a value;

based on the comparison of the difference to the value, adjusting a position of the catheter;

stimulating the first nerve using one or more of the plurality of proximal electrodes; and

stimulating the second nerve using one or more of the plurality of distal electrodes.

16. The method of claim 15, wherein the first nerve is a left phrenic nerve, and the second nerve is a right phrenic nerve.

17. The method of claim 15, wherein the difference between the first ECG signal and the second ECG signal is a difference between an amplitude of a portion of the first ECG signal and an amplitude of a portion of the second ECG signal.

18. The method of claim 15, wherein the steps of determining the difference and comparing occur a plurality of times during the inserting step.

19. The method of claim 15, wherein adjusting the position of the catheter includes moving the catheter away from a heart.

20. The method of claim 15, wherein at least one of stimulating the first nerve or stimulating the second nerve causes a contraction of a diaphragm.

21. The method of claim 15, further comprising sensing activity of the first nerve using one or more of the proximal electrodes and sensing activity of the second nerve using one or more of the distal electrodes.

22. A method for positioning an intravascular catheter, comprising:

inserting the intravascular catheter into;

     1) at least one of a left subclavian vein or a left jugular vein, and

     2) a superior vena cava, wherein the catheter includes a plurality of proximal electrodes configured to be positioned proximate a left phrenic nerve and a plurality of distal electrodes configured to be positioned proximate a right phrenic nerve;

at multiple positions of the catheter during the inserting step, using one or more electrodes of the plurality of proximal electrodes to acquire a first ECG signal, and using one or more electrodes of the plurality of distal electrodes to acquire a second ECG signal;

determining a difference between the first ECG signal and the second ECG signal at several of the multiple positions;

comparing each difference to a value;

based on the comparisons of each difference to the value, determining a desired position of the catheter for nerve stimulation;

stimulating the left phrenic nerve using one or more of the plurality of proximal electrodes; and

stimulating the right phrenic nerve using one of more of the plurality of distal electrodes.

23. The method of claim 22, further comprising advancing a distal end of the catheter into a region proximate an atrium of a heart.

24. The method of claim 23, wherein one of the multiple positions is a position in which the distal end of the catheter is proximate the atrium of the heart, and in the position, the comparison indicates a difference between an amplitude of the first ECG signal and an amplitude of the second ECG signal that exceeds the value.

25. The method of claim 24, further comprising moving the catheter away from the heart.

26. The method of claim 22, wherein stimulating the left phrenic nerve causes a diaphragm contraction, and stimulating the right phrenic nerve causes a diaphragm contraction.

27. The method of claim 22, wherein the proximal electrodes used to acquire the first ECG signal are configured to stimulate the left phrenic nerve, and the distal electrodes used to acquire the second ECG signal are configured to stimulate the right phrenic nerve.