Endovenous access and guidance system utilizing non-image based ultrasound

• US 9,204,819 B2
• Filed: 05/08/2006
• Issued: 12/08/2015
• 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): TURCHEN, ROCHELLE DEANNA
• Application Number:
  US11/431,140
• Publication Number:
  US 20070016072A1
• Time in Patent Office: 3,501 Days
• Field of Search: 600/437, 600/462, 600/466, 600/467, 600/472
• US Class Current: 1/1
• 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, 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. An endovenous access and guidance system, comprising:

an endovenous catheter;

an elongate flexible member configured to access a venous vasculature of a patient through the endovenous catheter;

a sensor disposed at a distal end of the elongate flexible member, the sensor being configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient;

a processor configured to;

receive the in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor,

determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a first spectral power of blood flow away from the sensor and a second spectral power of blood flow towards the sensor at a single point in time,

compare the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to one or more stored spectral power patterns,

determine, based on the comparison of the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to the one or more stored spectral power patterns, that;

blood flow within the venous vasculature of the patient is towards the sensor,

blood flow within the venous vasculature of the patient is away from the sensor, and

blood flow is indicative of the sensor being in proximity of a predetermined structure within the venous vasculature of the patient; and

enable output of;

a first indication when the processor determines that the blood flow within the venous vasculature of the patient is towards the sensor,

a second indication, different from the first indication, when the processor determines that the blood flow within the venous vasculature of the patient is away from the sensor, and

a third indication, different from the first indication and the second indication, when the processor determines that the blood flow is indicative of the sensor being in proximity of the predetermined structure within the venous vasculature of the patient.

2. The endovenous access and guidance system of claim 1, wherein the elongate flexible member comprises a guide wire.

3. The endovenous access and guidance system of claim 1, wherein the elongate flexible member comprises a stylet.

4. The endovenous access and guidance system of claim 1, wherein the elongate flexible member is configured to deliver a therapy to the patient.

5. The endovenous access and guidance system of claim 1, wherein the elongate flexible member defines a lumen that is configured to provide endovenous access for another device.

6. The endovenous access and guidance system of claim 1, wherein the processor is further configured to determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a venous blood flow direction, a venous blood flow velocity, a venous blood flow signature pattern, a pressure signature pattern, A-mode information, or a preferential non-random direction of flow.

7. The endovenous access and guidance system of claim 1, further comprising a divergent lens over the sensor.

8. The endovenous access and guidance system of claim 1, further comprising a plurality of lenses associated with the sensor.

9. The endovenous access and guidance system of claim 7, wherein the divergent lens is configured to attach the sensor to the elongate flexible member.

10. The endovenous access and guidance system of claim 1, wherein the sensor is a first sensor configured to transmit an ultrasound signal, the system further comprising a second sensor configured to receive the in vivo non-image based ultrasound information.

11. The endovenous access and guidance system of claim 1, further comprising a waveform synthesizer configured drive the sensor in a plurality of ultrasound transmission modes.

12. The endovenous access and guidance system of claim 1, further comprising a centering element configured to center the distal end of the elongate flexible member within a vessel of the venous vasculature of the patient.

13. The endovenous access and guidance system of claim 1, further comprising two or more additional sensors, wherein the sensor and the two or more additional sensors are attached to the elongate flexible member in an arrangement that mimics an endovascular junction.

14. The endovenous access and guidance system of claim 1, further comprising a steering guide configured to direct the elongate flexible member in response to feedback information derived from the first indication or the second indication.

15. The endovenous access and guidance system of claim 1, wherein the predetermined structure within the venous vasculature of the patient is a superior vena cava of the patient.

27. The endovenous access and guidance system of claim 1, wherein the processor is further configured to initiate a calibration to compute information related to a pattern, a threshold, or a combination of the pattern and the threshold based on the in vivo non-image based ultrasound information received from the sensor.

28. The endovenous access and guidance system of claim 27, wherein the processor stores a database of predetermined spectral power patterns identifying predetermined locations in the venous vasculature.

29. The endovenous access and guidance system of claim 1, wherein the processor is further configured to receive and process non-pulsatile, low velocity flow information.

33. The endovenous access and guidance system of claim 27, wherein the processor is further configured to initiate the calibration proximate a point of access to the venous vasculature of the patient.

35. The endovenous access and guidance system of claim 1, wherein the predetermined structure within the venous vasculature of the patient is a cavoatrial junction of the patient.

37. The endovenous access and guidance system of claim 1, wherein the processor is further configured to:

determine when the sensor is against a vessel wall within the venous vasculature of the patient or in an unknown location within the venous vasculature of the patient, and

enable output of a fourth indication when the processor determines that the sensor is against the vessel wall within the venous vasculature of the patient or in the unknown location within the venous vasculature of the patient.

41. The endovenous access and guidance system of claim 1, wherein the processor determined the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor at the single point in time by computing the Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

42. The endovenous access and guidance system of claim 41, wherein the processor is configured to compute the Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient by computing the Fast Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

43. The endovenous access and guidance system of claim 1, wherein the processor is further configured to:

compare the compare the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to a predetermined threshold; and

discard, based on the comparison of the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to the predetermined threshold, those spectral powers below the predetermined threshold.

44. The endovenous access and guidance system of claim 43, wherein the predetermined threshold a value between 10% and 20% of a peak spectral power of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

45. The endovenous access and guidance system of claim 1, wherein the processor is further configured to:

determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a first velocity of blood flow away from the sensor and a second velocity of blood flow towards the sensor at the single point in time;

determine a first pressure gradient for blood flow away from the sensor based on the first velocity and the first spectral power; and

determine a second pressure gradient for blood flow toward the sensor based on the second velocity and the second spectral power.

16. An endovenous access and guidance system, comprising:

an endovenous catheter;

an elongate flexible member configured to access a venous vasculature of a patient through the endovenous catheter;

a sensor disposed at a distal end of the elongate flexible member, the sensor being configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient;

a processor configured to;

receive the in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor,

determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a first spectral power of blood flow away from the sensor and a second spectral power of blood flow towards the sensor at a single point in time,

compare the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to one or more stored spectral power patterns,

determine, based on the comparison of the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to the one or more stored spectral power patterns, that;

blood flow within the venous vasculature of the patient is towards a heart of the patient,

blood flow within the venous vasculature of the patient is away from the heart of the patient, and

blood flow is indicative of the sensor being in proximity of a predetermined structure within the heart of the patient; and

enable output of;

a first indication when the processor determines that the blood flow within the venous vasculature of the patient is towards the heart,

a second indication, different from the first indication, when the processor determines that the blood flow within the venous vasculature of the patient is away from the heart, and

a third indication, different from the first indication and the second indication, when the processor determines that the blood flow is indicative of the sensor being in proximity of the predetermined structure within the heart of the patient.

17. The endovenous access and guidance system of claim 16, wherein the elongate flexible member comprises a guide wire.

18. The endovenous access and guidance system of claim 16, wherein the elongate flexible member comprises a stylet.

19. The endovenous access and guidance system of claim 16, wherein the elongate flexible member is configured to deliver a therapy to the patient.

20. The endovenous access and guidance system of claim 16, wherein the elongate flexible member defines a lumen that is configured to provide endovenous access for another device.

21. The endovenous access and guidance system of claim 16, wherein the processor is further configured to determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a venous blood flow direction, a venous blood flow velocity, a venous blood flow signature pattern, a pressure signature pattern, A-mode information, or a preferential non-random direction of flow.

22. The endovenous access and guidance system of claim 16, further comprising a divergent lens associated with the sensor.

23. The endovenous access and guidance system of claim 16, further comprising a centering element configured to center the distal end of the elongate flexible member within a vessel of the venous vasculature of the patient.

24. The endovenous access and guidance system of claim 16, further comprising two or more additional sensors, wherein the sensor and the two or more additional sensors are attached to the elongate flexible member in an arrangement that mimics an endovascular junction.

25. The endovenous access and guidance system of claim 16, wherein the predetermined structure within the heart of the patient is a superior vena cava of the patient.

26. The endovenous access and guidance system of claim 16, wherein the predetermined structure within the heart of the patient is a cavoatrial junction of the patient.

30. The endovenous access and guidance system of claim 16, wherein the processor is further configured to initiate a calibration to compute information related to a pattern, a threshold, or a combination of the pattern and the threshold based on the in vivo non-image based ultrasound information received from the sensor.

31. The endovenous access and guidance system of claim 30, wherein the processor stores a database of predetermined spectral power patterns identifying predetermined locations in the venous vasculature.

32. The endovenous access and guidance system of claim 16, wherein the processor is further configured to receive and process non-pulsatile, low velocity flow information.

34. The endovenous access and guidance system of claim 16, further comprising a plurality of lenses associated with the sensor.

36. The endovenous access and guidance system of claim 16, wherein the sensor is a first sensor configured to transmit an ultrasound signal, the system further comprising a second sensor configured to receive the in vivo non-image based ultrasound information.

38. The endovenous access and guidance system of claim 16, wherein the processor is further configured to:

determine when the sensor is against a vessel wall within the venous vasculature of the patient or in an unknown location within the venous vasculature of the patient, and

enable output of a fourth indication when the processor determines that the sensor is against the vessel wall within the venous vasculature of the patient or in the unknown location within the venous vasculature of the patient.

39. The endovenous access and guidance system of claim 16, further comprising a waveform synthesizer configured drive the sensor in a plurality of ultrasound transmission modes.

40. The endovenous access and guidance system of claim 16, wherein the sensor is a first sensor configured to receive the in vivo non-image based ultrasound information, the system further comprising a second sensor configured to transmit an ultrasound signal.

46. The endovenous access and guidance system of claim 16, wherein the processor determined the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor at the single point in time by computing the Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

47. The endovenous access and guidance system of claim 46, wherein the processor is configured to compute the Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient by computing the Fast Fourier Transform of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

48. The endovenous access and guidance system of claim 16, wherein the processor is further configured to:

compare the compare the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to a predetermined threshold; and

discard, based on the comparison of the first spectral power of blood flow away from the sensor and the second spectral power of blood flow towards the sensor to the predetermined threshold, those spectral powers below the predetermined threshold.

49. The endovenous access and guidance system of claim 48, wherein the predetermined threshold a value between 10% and 20% of a peak spectral power of the in vivo non-image based ultrasound information of the venous vasculature of the patient.

50. The endovenous access and guidance system of claim 16, wherein the processor is further configured to:

determine, based on the in vivo non-image based ultrasound information of the venous vasculature of the patient, a first velocity of blood flow away from the sensor and a second velocity of blood flow towards the sensor at the single point in time;

determine a first pressure gradient for blood flow away from the sensor based on the first velocity and the first spectral power; and

determine a second pressure gradient for blood flow toward the sensor based on the second velocity and the second spectral power.