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

• US 8,409,103 B2
• Filed: 05/08/2006
• Issued: 04/02/2013
• 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
• Primary Examiner(s): CHAO, ELMER M
• Application Number:
  US11/430,511
• Publication Number:
  US 20070016068A1
• Time in Patent Office: 2,521 Days
• Field of Search: 600/407, 600/454, 600/479, 600/437, 600/443, 600/448, 600/467, 600/468
• 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. 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:

inserting the instrument within a vein of the venous system;

acquiring patient specific data using the instrument prior to moving the instrument within the vein;

transmitting an in vivo non-imaging ultrasound signal into the vein using an ultrasound transducer on a distal portion of the instrument;

receiving a reflected in vivo non-imaging ultrasound signal from the vein using the instrument;

processing, using a processor, the reflected in vivo non-imaging ultrasound signal to generate a processed ultrasound signal;

calculating, using the processor, one or more non-pulsatile blood flow features extracted from the processed ultrasound signal, wherein the one or more non-pulsatile blood flow features includes a ratio of a blood flow velocity away from the ultrasound transducer and a blood flow velocity towards the ultrasound transducer;

determining, using the processor, a position of the instrument within the venous system based on the calculated one or more non-pulsatile blood flow features;

displaying to a user a first indication of the determined position within the venous system;

moving the instrument based on whether the displayed first indication is a desired indication; and

determining, using the processor, whether the instrument has reached the superior vena cava based on the calculated one or more non-pulsatile blood flow features.

2. The method of claim 1, further comprising:

after the moving, transmitting another in vivo non-imaging ultrasound signal using the instrument;

receiving another reflected in vivo non-imaging ultrasound signal using the instrument;

processing the another in vivo non-imaging ultrasound reflected signal to determine the another position of the instrument;

displaying to a user a second indication different from the first indication of the determined another position; and

moving the instrument to another position based on whether the displayed second indication is the desired indication.

3. The method of claim 2, wherein the moving to another position comprises moving the instrument into another vein.

4. The method of claim 2, wherein the moving to another position is selected from the group consisting of advancing the instrument through the vein towards a target region, holding the instrument at the another position, and withdrawing the instrument in the vein towards the position.

5. The method of claim 2, wherein the second indication is not the desired indication and the moving to another position comprises withdrawing the instrument.

6. The method of claim 5, wherein the second indication is indicative of passing a target region.

7. The method of claim 5, wherein the second indication is indicative of entering a chamber of a heart.

8. The method of claim 2, wherein the second indication is the desired indication and the moving to another position comprises holding the instrument in the another position.

9. The method of claim 8, wherein the desired indication is indicative of reaching a target region.

10. The method of claim 9, further comprising after the holding, verifying placement at the target region without using the instrument.

11. The method of claim 2, wherein the first and second indications are selected from among a plurality of predetermined path progress indications.

12. The method of claim 2, further comprising advancing the instrument until the desired indication is indicated.

13. The method of claim 2, wherein the displaying of the first indication comprises illuminating a light on a display device and the displaying of the second indication comprises illuminating a different light on the display device.

14. The method of claim 2, wherein the another position is the coronary sinus.

15. The method of claim 2, wherein the another position is the superior vena cava.

16. The method of claim 15, wherein the position is a basilic or cephalic vein.

17. The method of claim 2, wherein the processing of the another reflected in vivo non-imaging ultrasound signal comprises determining the another position relative to the position.

18. The method of claim 11, wherein the displaying comprises displaying the progress of the instrument from an insertion point to a targeted delivery point.

19. The method of claim 1, wherein the acquiring comprises computing, using a processor, a blood flow pattern, a threshold, or a combination of the same.

20. The method of claim 19, wherein the acquiring comprises comparing, using the processor, the computed pattern, threshold, or combination against a pre-stored database of flow patterns identifying certain locations in the venous system.

21. The method of claim 19, wherein the acquiring comprises storing the computed pattern, threshold, or combination in a patient specific database.

22. The method of claim 1, wherein the acquiring comprises acquiring data from the vein using the instrument.

23. The method of claim 1, wherein the acquiring comprises evaluating patient specific data, using the processor, based on preferential non-random direction of flow.

24. The method of claim 1, further comprising, after the acquiring, calibrating the instrument based on the acquired patient specific data and then notifying the user that calibration is complete.

25. The method of claim 1, wherein the blood flow features comprises a blood flow power spectrum.

26. The method of claim 25, wherein the blood flow power spectrum comprises a blood flow power spectrum away from the ultrasound transducer and a blood flow power spectrum towards the ultrasound transducer.

27. The method of claim 1, wherein the blood flow features comprises a ratio of a blood flow power spectrum away from the transducer and a blood flow power spectrum towards the transducer.

28. The method of claim 1, wherein the blood flow features comprises a blood flow velocity towards the ultrasound transducer and a blood flow velocity away from the ultrasound transducer.

29. The method of claim 28, wherein the blood flow velocities are preferential non-random velocities having a power spectrum above a predetermined power spectrum threshold.

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

inserting the instrument within a vein of the venous system;

transmitting an in vivo non-imaging ultrasound signal into the vein using an ultrasound transducer on a distal portion of the instrument;

receiving a reflected in vivo non-imaging ultrasound signal from the vein using the instrument;

processing, using a processor, the reflected in vivo non-imaging ultrasound signal to generate a processed ultrasound signal;

calculating, using the processor, one or more non-pulsatile blood flow features extracted from the processed ultrasound signal, wherein the one or more non-pulsatile blood flow features includes a ratio of a blood flow power spectrum away from the transducer and a blood flow power spectrum towards the transducer;

determining, using the processor, a position of the instrument within the venous system based on the calculated one or more non-pulsatile blood flow features;

displaying to a user a first indication of the determined position within the venous system; and

moving the instrument based on whether the displayed first indication is a desired indication.

31. The method of claim 30, wherein the blood flow features further comprises a blood flow velocity towards the ultrasound transducer and a blood flow velocity away from the ultrasound transducer.

32. The method of claim 31, wherein the blood flow velocities are preferential non-random velocities having a power spectrum above a predetermined power spectrum threshold.

33. The method of claim 32, wherein the predetermined power spectrum threshold is between 10% and 20% of peak power.

34. The method of claim 30, wherein the blood flow features further comprises a ratio of blood flow velocity towards the ultrasound transducer and a blood flow velocity away from the ultrasound transducer.

35. The method of claim 30, further comprising determining, using the processor, whether the instrument has been correctly inserted into the vein or incorrectly inserted into an artery.

36. The method of claim 35, wherein the step of determining is based at least in part on detecting whether the blood flow is pulsatile or non-pulsatile.

37. The method of claim 35, wherein the step of determining is based at least in part on determining whether the blood flow is predominantly towards the transducer or away from the transducer.

38. The method of claim 30, wherein the blood flow features further comprises a velocity profile.

39. The method of claim 30, further comprising providing an audio indication of the determined location of the instrument within the venous system.

40. The method of claim 30, wherein the blood flow features further comprises a comparison between a blood flow velocity towards the ultrasound transducer and a blood flow velocity between away from the ultrasound transducer.