Ultrasound methods of positioning guided vascular access devices in the venous system

• US 20070016068A1
• Filed: 05/08/2006
• Published: 01/18/2007
• 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
• Granted Patent: US 8,409,103 B2
• Time in Patent Office: Days
• US Class Current: 600/468
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• 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 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• 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 8/0841 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 8/4472 Wireless probes
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/5207 : involving processing of raw data to produce diagnostic data, e.g. for generating an image reconstruction G06T11/00

Abstract

The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system. The system comprises: an elongate flexible member adapted and configured to access the venous vasculature of a patient; a sensor disposed at a distal end of the elongate flexible member and configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient; a processor configured to receive and process in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor and to provide position information regarding the position of the distal end of the elongate flexible member within the venous vasculature of the patient; and an output device adapted to output the position information from the processor.

Claims

1. A method for positioning an instrument in the venous system of a body, comprising:

accessing the venous system of the body;

positioning an instrument in the venous system of the body;

using the instrument to transmit an ultrasound signal into the venous system of the body;

using the instrument to receive a reflected ultrasound signal from the vasculature indicating flow rates between 2 and 20 cm/s;

processing the reflected ultrasound signal to determine one or more parameters from a group consisting of;

a venous blood flow direction, a venous blood flow velocity, a venous blood flow signature pattern, a pressure signature pattern, A-mode information and a preferential non-random direction of flow; and

advancing the instrument within the vasculature using the one or more of the determined parameter or parameters within the vasculature.

2. The method for positioning an instrument in the vasculature of a body according to claim 1 wherein using the instrument to transmit an ultrasound signal into the vasculature of the body comprises transmitting or receiving an A mode ultrasound signal into or from the vasculature of the body.

3. The method for positioning an instrument in the vasculature of a body according to claim 1 wherein using the instrument to transmit an ultrasound signal into the vasculature of the body comprises transmitting or receiving Doppler ultrasound signal into or from the vasculature of the body.

4. The method for positioning an instrument in the vasculature of a body according to claim 1 wherein using the instrument to transmit an ultrasound signal into the vasculature of the body comprises transmitting or receiving a non-imaging target tracking ultrasound signal into or from the vasculature of the body.

5. The method for positioning an instrument in the vasculature of a body according to claim 1 wherein processing the reflected ultrasound signal to determine a flow pattern determines a flow direction within the vasculature towards the instrument and further comprises processing the reflected ultrasound signal to determine a flow pattern determines a flow direction away from the instrument.

6. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of a signal indicating a specific blood flow pattern.

7. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of a signal indicating a specific pressure pattern.

8. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the position of the instrument relative to the caval-atrial junction.

9. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of flow after processing the reflected ultrasound signal to determine the presence of both antegrade and retrograde flow.

10. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of flow away from the instrument and after processing the reflected ultrasound signal to determine the presence of flow both away and towards the instrument.

11. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of a signal indicating a specific structure.

12. The method for positioning an instrument in the vasculature of a body according to claim 11 wherein the specific structure is a valve of a heart.

13. The method for positioning an instrument in the vasculature of a body according to claim 11 wherein the specific structure is a chamber of a heart.

14. The method for positioning an instrument in the vasculature of a body according to claim 11 wherein the specific structure is a blood vessel wall.

15. The method for positioning an instrument in the vasculature of a body according to claim 11 wherein the specific structure is a heart wall.

16. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the presence of a signal indicating a position where two or more vessels join.

17. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a superior vena cava and an inferior vena cava.

18. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise an inferior vena cava and a renal vein.

19. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a right common iliac vein and a left common iliac vein.

20. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise an external iliac vein and an internal iliac vein.

21. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a right brachiocephalic vein and a left brachiocephalic vein.

22. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a superior vena cava and an azygous vein.

23. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a common femoral vein and a great saphenous vein.

24. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a superficial femoral vein and a deep femoral vein.

25. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a popliteal vein and a lesser saphenous vein.

26. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a perforator vein and a superficial vein.

27. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a perforator vein and a deep tibial vein.

28. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a great saphenous vein and a varicose vein.

29. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a jugular vein and a subclavian vein.

30. The method for positioning an instrument in the vasculature of a body according to claim 16 wherein the two or more vessels comprise a cephalic vein and an axillary vein.

31. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising:

using the instrument determine a location to secure a device within the vasculature of a body; and

securing the device to the body to maintain the device in the location determined by the instrument.

32. The method for positioning an instrument in the vasculature of a body according to claim 31 further comprising:

using the instrument to calculate the current position of the device; and

determining if the device is in the location determined by the instrument by comparing the current calculated position of the device to the location determined by the instrument.

33. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the position of the instrument within the right atrium relative to the coronary sinus.

34. The method for positioning an instrument in the vasculature of a body according to claim 1 further comprising processing the reflected ultrasound signal to determine the position of the instrument within the left atrium relative to a pulmonary vein.