Endovascular devices and methods of use

• US 9,339,207 B2
• Filed: 01/23/2009
• Issued: 05/17/2016
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Vasonova, Inc. (Teleflex Incorporated)
• Inventors: Grunwald, Sorin, Hill, Bradley, Cheng, E. Tina
• Primary Examiner(s): TURCHEN, ROCHELLE DEANNA
• Application Number:
  US12/359,195
• Publication Number:
  US 20090177090A1
• Time in Patent Office: 2,671 Days
• Field of Search: 600/407, 600/437, 600/438, 600/450, 600/454, 600/459, 600/462, 600465-467, 600/470
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 : Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/366 : Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/369 : Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 7/04 : Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61B 8/02 : Measuring pulse or heart rate
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/08 : Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/42 : Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 8/461 : Displaying means of special interest
• CPC Class Codes: A61B 8/463 : characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/465 : adapted to display user selection data, e.g. icons or menus
• CPC Class Codes: A61B 8/488 : involving Doppler signals
• CPC Class Codes: A61B 8/565 : involving data transmission via a network
• CPC Class Codes: G09B 23/288 : for artificial respiration or heart massage

Abstract

A method for evaluating flow characteristics in a vessel of a patient includes the steps of positioning a catheter having a balloon at a measuring location within the vessel; transmitting an ultrasound signal into the vessel while the balloon catheter is within the measuring location; evaluating a reflection of the ultrasound signal to determine a flow parameter within the vessel while the catheter is in the measuring position; expanding the balloon within the vessel at the measuring location; and stopping the expanding step when the result of the evaluating step is that the flow through the vessel is substantially stopped. In some embodiments, the method may further comprise the step of detecting an endovascular electrogram signal. The method may be designed for evaluating flow characteristics in a vessel of a patient while enabling the prevention of a balloon from over-expanding and/or over-distending a vessel of a patient.

Claims

1. A method of evaluating flow characteristics in a vessel of a patient, the method comprising:

inserting a catheter comprising a balloon, an ultrasound transducer and an endovascular electrogram sensor into the vessel of the patient, wherein the ultrasound transducer is distal of the balloon and the endovascular electrogram sensor when the balloon is expanded;

transmitting, from the ultrasound transducer of the catheter, a first non-imaging ultrasound signal into the vessel when the balloon is not expanded;

receiving a first reflected non-imaging ultrasound signal;

detecting an endovascular electrogram signal using the endovascular electrogram sensor;

determining, using a processor, a first blood flow signature pattern within the vessel based on the first reflected non-imaging ultrasound signal, the first blood flow signature pattern being different from the first reflected non-imaging ultrasound signal;

determining, using the processor, the location of the catheter within the vessel based on the first blood flow signature pattern and the detected endovascular electrogram signal;

initiating expansion of the balloon within the vessel at a measuring location within the vessel, the measuring location within the vessel being different from the determined location within the vessel;

transmitting, from the ultrasound transducer of the catheter, a second non-imaging ultrasound signal into the vessel while the balloon is being expanded;

receiving a second reflected non-imaging ultrasound signal;

determining, using the processor, a second blood flow signature pattern within the vessel based on the second reflected non-imaging ultrasound signal, the second blood flow signature pattern being different from the first blood flow signature pattern and from the second reflected non-imaging ultrasound signal;

determining that the second blood flow signature pattern indicates that flow through the vessel has stopped; and

stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel in response to the determination that the second blood flow signature pattern indicates that flow through the vessel has stopped.

2. The method of claim 1, wherein the measuring location is within a pulmonary artery.

3. The method of claim 2, wherein the measuring location is within a branch of the pulmonary artery.

4. The method of claim 2, wherein the measuring location is a pulmonary artery wedge position.

5. The method of claim 1, wherein the ultrasound signals are A-mode ultrasound signals.

6. The method of claim 1, wherein the ultrasound signals are Doppler ultrasound signals.

7. The method of claim 1, wherein the blood flow signature patterns are blood flow velocities.

8. The method of claim 1, wherein the blood flow signature patterns are pressure signature patterns.

9. The method of claim 1, further comprising:

determining a pressure at the measuring location;

determining that the pressure at the measuring location is below a mean pulmonary arterial pressure; and

stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel comprises stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel in response to the determination that the pressure at the measuring location is below the mean pulmonary arterial pressure.

10. The method of claim 8, wherein stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel comprises stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel in response to a determination that a pressure signature pattern at the measuring location is consistent with a pulmonary capillary wedge pressure signature pattern.

11. The method of claim 10, wherein the pressure signature pattern indicates a pressure lower than a pulmonary artery pressure and more static than a pulmonary artery pressure.

12. The method of claim 1, further comprising deflating the balloon at the measuring location after stopping the expansion of the balloon.

13. The method of claim 12, further comprising:

transmitting, from the ultrasound transducer of the catheter, a third non-imaging ultrasound signal into the vessel after the balloon is deflated;

receiving a third reflected non-imaging ultrasound signals; and

determining, using the processor, a third blood flow signature pattern within the vessel based on the third reflected non-imaging ultrasound signal, the third blood flow signature pattern being different from the third reflected non-imaging ultrasound signal.

14. The method of claim 13, wherein the third blood flow signature pattern indicates turbulent blood flow after the balloon deflates and decouples from the vessel wall.

15. The method of claim 1, wherein the endovascular electrogram signal comprises electrical activity of the heart.

16. The method of claim 15, wherein the electrical activity of the heart is related to the sino-atrial node of the heart.

17. The method of claim 1, wherein initiating expansion of the balloon within the vessel at the measuring location comprises timing the initiation of the expansion of the balloon based on the endovascular electrogram signal.

18. The method of claim 1, further comprising measuring a parameter used to determine cardiac function.

19. The method of claim 18, wherein the parameter is pulmonary artery occlusion pressure.

20. The method of claim 18, wherein the parameter used to determine cardiac function is based on the endovascular electrogram signal.

21. The method of claim 20, wherein the parameter is arterial flow.

22. The method of claim 1, wherein the first blood flow signature pattern is a blood flow direction.

23. The method of claim 22, wherein the blood flow direction comprises a blood flow directed towards the ultrasound transducer or a blood flow directed away from the ultrasound transducer.

24. The method of claim 1, wherein the first blood flow signature pattern is a blood flow velocity.

31. The method of claim 1, further comprising determining a mean pulmonary arterial pressure.

32. The method of claim 24, wherein the blood flow velocity is a blood flow velocity towards the catheter or a blood flow velocity away from the catheter.

33. The method of claim 1, wherein the first blood flow signature pattern is a blood flow power spectrum towards the catheter or a blood flow power spectrum away from the catheter.

35. The method of claim 1, wherein:

receiving the first reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the first reflected non-imaging ultrasound signal; and

receiving the second reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the second reflected non-imaging ultrasound signal.

25. A method of evaluating flow characteristics in a vessel of a patient, the method comprising:

inserting a catheter comprising a balloon, an ultrasound transducer and an endovascular electrogram sensor into the vessel of the patient;

transmitting, from the ultrasound transducer of the catheter, a first non-imaging ultrasound signal into the vessel;

receiving a first reflected non-imaging ultrasound signal;

detecting an endovascular electrogram signal using the endovascular electrogram sensor;

determining, using a processor, a first flow parameter within the vessel based on the first reflected non-imaging ultrasound signal, the first flow parameter being different from the first reflected non-imaging ultrasound signal;

determining, using the processor, the location of the catheter within the vessel based on the first flow parameter and the detected endovascular electrogram signal;

transmitting, from the ultrasound transducer of the catheter, a second non-imaging ultrasound signal into the vessel while the catheter is at a measuring location within the vessel, the measuring location within the vessel being different from the determined location within the vessel;

receiving a second reflected non-imaging ultrasound signal;

determining, using the processor, a second flow parameter of the vessel based on the second reflected non-imaging ultrasound signal while the balloon is in a first configuration, the second flow parameter being different from the first flow parameter and from the second reflected non-imaging ultrasound signal;

initiating expansion of the balloon within the vessel at the measuring location within the vessel;

transmitting, from the ultrasound transducer of the catheter, a third ultrasound signal into the vessel while the balloon is being expanded;

receiving a third reflected non-imaging ultrasound signal;

determining, using the processor, a third flow parameter of the vessel based on the third reflected non-imaging ultrasound signal, the third flow parameter being different from the first flow parameter, from the second flow parameter and from the third reflected non-imaging ultrasound signal;

determining that the third flow parameter indicates that the flow through the vessel has stopped;

returning the balloon to the first configuration after determining that the third flow parameter indicates that the flow through the vessel has stopped;

transmitting a fourth ultrasound signal into the vessel after the balloon is returned to the first configuration;

receiving a fourth reflected non-imaging ultrasound signal;

determining, using the processor, a fourth flow parameter of the vessel based on the fourth reflected non-imaging ultrasound signal, the fourth flow parameter being different from the first flow parameter, from the second flow parameter, from the third flow parameter and from the fourth reflected non-imaging ultrasound signal;

comparing the second flow parameter with the fourth flow parameter; and

determining, in response to the comparison of the second flow parameter to the fourth flow parameter, that the second flow parameter is equal to the fourth flow parameter to verify that the blood flow through the vessel has returned to the same state that existed before the balloon was expanded.

26. The method of claim 25, wherein the first configuration of the balloon is a stowed configuration.

27. The method of claim 25, wherein the first configuration of the balloon is a partially inflated configuration.

28. The method of claim 25, wherein the first flow parameter, the second flow parameter, the third flow parameter, and the fourth flow parameter are blood flow signature patterns.

34. The method of claim 25, wherein the ultrasound transducer is distal of the balloon when the balloon is expanded.

36. The method of claim 25, wherein:

receiving the first reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the first reflected non-imaging ultrasound signal;

receiving the second reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the second reflected non-imaging ultrasound signal;

receiving the third reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the third reflected non-imaging ultrasound signal; and

receiving the fourth reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the fourth reflected non-imaging ultrasound signal.

29. A method of evaluating flow characteristics in a vessel of a patient, comprising:

inserting a catheter comprising a balloon, an ultrasound transducer and an endovascular electrogram sensor into the vessel of the patient, wherein the ultrasound transducer is distal of the balloon and the endovascular electrogram sensor when the balloon is expanded;

transmitting, from the ultrasound transducer of the catheter, a first non-imaging ultrasound signal into the vessel when the balloon is not expanded;

receiving a first reflected non-imaging ultrasound signal;

detecting a first endovascular electrogram signal using the endovascular electrogram sensor;

determining, using a processor, a first blood flow signature pattern within the vessel based on the first reflected non-imaging ultrasound signal, the first blood flow signature pattern being different from the first reflected non-imaging ultrasound signal;

determining, using the processor, the location of the catheter within the vessel based on the first blood flow signature pattern and the first endovascular electrogram signal;

initiating expansion of the balloon within the vessel at a measuring location within the vessel;

transmitting, from the ultrasound transducer of the catheter, a second non-imaging ultrasound signal into the vessel while the balloon is being expanded;

receiving a second reflected non-imaging ultrasound signal;

determining, using the processor, a second blood flow signature pattern within the vessel based on the second reflected non-imaging ultrasound signal, the second blood flow signature pattern being different from the first blood flow signature pattern and from the second reflected non-imaging ultrasound signal;

stopping the expansion of the balloon while maintaining the stoppage of flow through the vessel in response to the determination that the second blood flow signature pattern indicates that the flow through the vessel is stopped;

detecting, from the endovascular electrogram sensor, a second endovascular electrogram signal; and

using the second endovascular electrogram signal to trigger the transmitting steps or determining steps.

30. The method of claim 29, wherein the second blood flow signature pattern is a pressure signature pattern.

37. The method of claim 29, wherein:

receiving the first reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the first reflected non-imaging ultrasound signal; and

receiving the second reflected non-imaging ultrasound signal comprises receiving, using the ultrasound transducer of the catheter, the second reflected non-imaging ultrasound signal.