Apparatus and Method for Endovascular Device Guiding and Positioning Using Physiological Parameters

• US 20090005675A1
• Filed: 06/26/2008
• Published: 01/01/2009
• 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, Cheng, E. Tina, Hill, Bradley, Samson, Wilfred J., Sander, Fiona Maria
• Granted Patent: US 8,597,193 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• 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

An endovascular access and guidance system has an elongate body with a proximal end and a distal end; a non-imaging ultrasound transducer on the elongate body configured to provide in vivo non-image based ultrasound information of the vasculature of the patient; an endovascular electrogram lead on the elongate body in a position that, when the elongate body is in the vasculature, the endovascular electrogram lead electrical sensing segment provides an in vivo electrogram signal of the patient; a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and an output device configured to display a result of information processed by the processor. An endovascular device has an elongate body with a proximal end and a distal end; a non-imaging ultrasound transducer on the elongate body; and an endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the endovascular electrogram lead is in contact with blood. The method of positioning an endovascular device in the vasculature of a body is performed by advancing the endovascular device into the vasculature; transmitting a non-imaging ultrasound signal into the vasculature using a non-imaging ultrasound transducer on the endovascular device; receiving a reflected ultrasound signal with the non-imaging ultrasound transducer; detecting an endovascular electrogram signal with a sensor on the endovascular device; processing the reflected ultrasound signal received by the non-imaging ultrasound transducer and the endovascular electrogram signal detected by the sensor; and positioning the endovascular device based on the processing step.

Claims

1. A method of positioning an endovascular device in the vasculature of a body, comprising:

advancing the endovascular device into the vasculature;

transmitting a non-imaging ultrasound signal into the vasculature using a non-imaging ultrasound transducer on the endovascular device;

receiving a reflected ultrasound signal with the non-imaging ultrasound transducer;

detecting an endovascular electrogram signal with a sensor on the endovascular device; and

processing the reflected ultrasound signal received by the non-imaging ultrasound transducer and the endovascular electrogram signal detected by the sensor;

positioning the endovascular device based on the processing step.

2. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

displaying a result of the processing step.

3. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to venous blood flow direction.

4. The method of positioning an endovascular device in the vasculature of a body according to claim 3 wherein the venous flow direction comprises a flow directed towards the sensor and a flow directed away from the sensor.

5. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to venous blood flow velocity.

6. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to venous blood flow signature pattern.

7. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to a pressure signature pattern.

8. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to ultrasound A-mode information.

9. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to a preferential non-random direction of flow within a reflected ultrasound signal.

10. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to electrical activity of the heart.

11. The method of positioning an endovascular device in the vasculature of a body according to claim 10 wherein the electrical activity of the heart is related to the sino-atrial node of the heart.

12. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to electrical activity of the brain.

13. The method of positioning an endovascular device in the vasculature of a body according to claim 2 wherein the result of the processing step includes information related to electrical activity of a muscle.

14. The method of positioning an endovascular device in the vasculature of a body according to claim 2 the displaying step further comprising a visual indication of the position of the device.

15. The method of positioning an endovascular device in the vasculature of a body according to claim 2 the displaying step further comprising:

a color based indication of the position of the device.

16. The method of positioning an endovascular device in the vasculature of a body according to claim 2 the displaying step further comprising:

a sound based indication of the position of the device.

17. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

collecting the reflected ultrasound signal in synchrony with an endovascular electrogram signal received by the sensor.

18. The method of positioning an endovascular device in the vasculature of a body according to claim 17 wherein the endovascular electrogram comprises electrical activity from the heart.

19. The method of positioning an endovascular device in the vasculature of a body according to claim 17 wherein the collecting step is performed in synchrony during the PR interval.

20. The method of positioning an endovascular device in the vasculature of a body according to claim 17 wherein the collecting step is performed in synchrony with a portion of the P-wave.

21. The method of positioning an endovascular device in the vasculature of a body according to claim 17 wherein the endovascular electrogram comprises an electrical activity from the brain.

22. The method of positioning an endovascular device in the vasculature of a body according to claim 17 wherein the endovascular electrogram comprises an electrical activity from a muscle.

23. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

detecting an endovascular electrogram signal with a sensor positioned on the patient.

24. The method of positioning an endovascular device in the vasculature of a body according to claim 23 wherein the processing step further comprises:

comparing the endovascular electrogram signal from the sensor on the device to the endovascular electrogram signal on the patient.

25. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

detecting an endovascular electrogram signal with a second sensor positioned on the device.

26. The method of positioning an endovascular device in the vasculature of a body according to claim 25 the processing step further comprising:

comparing the endovascular electrogram signal from the sensor on the device to the endovascular electrogram signal from the second sensor on the device.

27. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

verifying that the length of the endovascular device inserted into the body is equivalent to the estimated device length prior to the procedure.

28. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

inputting into the system the length of the endovascular device inserted in the body.

29. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

identifying a structure in the vasculature using non-imaging ultrasound information in the reflected ultrasound signal.

30. The method of positioning an endovascular device in the vasculature of a body according to claim 29 wherein the non-imaging ultrasound information comprises using A-mode ultrasound to identify the structure in the vasculature.

31. The method of positioning an endovascular device in the vasculature of a body according to claim 29 wherein the non-imaging ultrasound information comprises using Doppler ultrasound information to identify a flow pattern in proximity to the structure.

32. The method of positioning an endovascular device in the vasculature of a body according to claim 1 wherein the transmitting step, the receiving step and the processing step are performed only when a selected endovascular electrogram signal is detected.

33. The method of positioning an endovascular device in the vasculature of a body according to claim 32 wherein the selected endovascular electrogram signal is a portion of an ECG wave.

34. The method of positioning an endovascular device in the vasculature of a body according to claim 32 wherein the selected endovascular electrogram signal is a portion of an EEG wave.

35. The method of positioning an endovascular device in the vasculature of a body according to claim 32 wherein the selected endovascular electrogram signal is a portion of an EMG wave.

36. The method of positioning an endovascular device in the vasculature of a body according to claim 1 wherein the processing step is performed only on a portion of the reflected ultrasound signals that correspond to a selected electrogram trigger signal.

37. The method of positioning an endovascular device in the vasculature of a body according to claim 36 wherein the selected electrogram trigger signal is a portion of an ECG wave.

38. The method of positioning an endovascular device in the vasculature of a body according to claim 36 wherein the selected electrogram trigger signal is a portion of an EEG wave.

39. The method of positioning an endovascular device in the vasculature of a body according to claim 36 wherein the selected electrogram trigger signal is a portion of an EMG wave.

40. The method of positioning an endovascular device in the vasculature of a body according to claim 1, the processing step further comprising:

processing the reflected ultrasound signal by comparing the flow energy directed away from the endovascular device to the flow energy directed towards the endovascular device.

41. The method of positioning an endovascular device in the vasculature of a body according to claim 40 further comprising:

selecting for comparison the flow energy related to blood flow within the range of 2 cm/sec to 25 cm/sec.

42. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

processing the reflected ultrasound signal to identify the caval-atrial junction.

43. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the reflected ultrasound signal to detect an indicia of pulsatile flow in the flow pattern.

44. The method of positioning an endovascular device in the vasculature of a body according to claim 43 wherein the indicia of pulsatile flow is a venous flow pattern.

45. The method of positioning an endovascular device in the vasculature of a body according to claim 43 wherein the indicia of pulsatile flow is an arterial flow pattern.

46. The method of positioning an endovascular device in the vasculature of a body according to claim 43 wherein the indicia of pulsatile flow is an atrial function of the heart.

47. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the reflected ultrasound signal to determine the highest average velocity of a velocity profile.

48. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the endovascular electrogram signal to determine peak to peak amplitude changes in an electrogram complex.

49. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the endovascular electrogram signal to determine peak to peak amplitude changes of an QRS complex in an electrocardiogram.

50. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the endovascular electrogram signal to determine peak to peak amplitude changes of an R-wave in an electrocardiogram.

51. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the endovascular electrogram signal to determine peak to peak amplitude changes of an P-wave in an electrocardiogram.

52. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the endovascular electrogram signal to compare the relative amplitude of an P-wave to the relative amplitude of another portion of an electrocardiogram.

53. The method of positioning an endovascular device in the vasculature of a body according to claim 52 wherein the another portion of an electrocardiogram comprises an QRS complex.

54. The method of positioning an endovascular device in the vasculature of a body according to claim 1 the processing step further comprising:

processing the reflective ultrasound signal to determine a blood flow velocity profile and processing the detected endovascular electrogram signal to determine a shape of the intravascular electrocardiogram.

55. The method of positioning an endovascular device in the vasculature of a body according to claim 54 the processing step further comprising:

correlating the blood flow velocity profile and the shape of the intravascular electrocardiogram to determine the location of the endovascular device within the vasculature.

56. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step to determine the position of the endovascular device relative to the caval-atrial junction and to the sino-atrial node.

57. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step to determine the position of the endovascular device relative to the superior vena cava.

58. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step to determine the position of the endovascular device relative to the internal jugular vein.

59. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step to determine the position of the endovascular device relative to the subclavian vein.

60. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

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

securing the endovascular device along with the device to the body to maintain the device in the location determined by the endovascular device.

61. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

calculating a current position of the device; and

comparing the calculated current position of the device to a location indicated by the processing step.

62. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step and the positioning step until the endovascular device is positioned within the right atrium relative to the coronary sinus.

63. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step and the positioning step until the endovascular device is positioned within the left atrium relative to a pulmonary vein.

64. The method of positioning an endovascular device in the vasculature of a body according to claim 1 further comprising:

performing the processing step and the positioning step until the endovascular device is positioned within the aorta.

65. An endovascular access and guidance system, comprising:

an elongate body with a proximal end and a distal end;

a non-imaging ultrasound transducer on the elongate body configured to provide in vivo non-image based ultrasound information of the vasculature of the patient;

an endovascular electrogram lead on the elongate body in a position that, when the elongate body is in the vasculature, the endovascular electrogram lead electrical sensing segment provides an in vivo electrogram signal of the patient;

a processor configured to receive and process a signal from the non-imaging ultrasound transducer and a signal from the endovascular electrogram lead; and

an output device configured to display a result of information processed by the processor.

66. An endovascular access and guidance system according to claim 65 wherein the output device displays a result related to a position of the elongate body within the vasculature of the patient.

67. The endovascular access and guidance system of claim 65 wherein the processor is further configured to process a signal from the non-image ultrasound transducer and to indicate in the output device information related to the presence of a structure in the field of view of the non-imaging ultrasound transducer.

68. The endovascular access and guidance system of claim 65 wherein a result of information processed by the processor comprises:

an indication of a position or a movement of the elongate body within the vasculature based on in vivo non-image based ultrasound information and in vivo electrogram information.

69. The endovascular access and guidance system of claim 65 wherein the processor is further configured to receive and process a signal from the non-imaging ultrasound transducer comprising a signal from at least one of the 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 to receive and process a signal from the endovascular electrogram lead the signal comprising at least one of the group consisting of;

an electrocardiogram signal, a P-wave pattern, a QRS-complex pattern, a T-wave pattern, an EEG signal and an EMG signal.

70. The endovascular access and guidance system of claim 65 further comprising:

a driver coupled to the ultrasound transducer adapted to drive the ultrasound transducer in response to an electrogram signal.

71. The endovascular access and guidance system of claim 70 wherein the driver coupled to the ultrasound transducer is adapted to drive the ultrasound transducer in a plurality of ultrasound transmission modes.

72. The endovascular access and guidance system of claim 65 further comprising:

a second endovascular electrogram lead on the elongate body positioned distal to the endovascular electrogram lead wherein the of the patient wherein the processor is further configured to receive and process a signal from the second endovascular electrogram lead.

73. The endovascular access and guidance system of claim 72 wherein the processor is further configured to compare the signal from the endovascular electrogram lead and the second endovascular electrogram lead.

74. The endovascular access and guidance system of claim 73 wherein the signal from the endovascular electrogram lead comprises a target electrogram signal and the second endovascular electrogram lead comprises a baseline electrogram signal.

75. The endovascular access and guidance system of claim 74 wherein the target electrogram signal and the baseline electrogram signal are related to ECG.

76. The endovascular access and guidance system of claim 74 wherein the target electrogram signal and the baseline electrogram signal are related to EMG.

77. The endovascular access and guidance system of claim 74 wherein the target electrogram signal and the baseline electrogram signal are related to EEG.

78. The endovascular access and guidance system of claim 65, the processor further configured to store a signal received from the non-imaging ultrasound transducer and a signal received from the endovascular electrogram lead.

79. The endovascular access and guidance system of claim 78, the processor further configured to process a portion of the stored signal received from the non-imaging ultrasound transducer that corresponds to a signal received from the endovascular electrogram lead.

80. The endovascular access and guidance system of claim 79, wherein the signal received from the endovascular electrogram lead comprised a P-wave.

81. The endovascular access and guidance system of claim 65 further comprising:

an additional sensor for detecting a physiological parameter of the vasculature, the sensor positioned along the elongate body; and

the processor further configured to receive and process a signal from the additional sensor.

82. The endovascular access and guidance system of claim 81 wherein the additional sensor for detecting a physiological parameter of the vasculature is a pressure sensor or an optical sensor.

83. An endovascular device, comprising:

an elongate body with a proximal end and a distal end;

a non-imaging ultrasound transducer on the elongate body; and

an endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the endovascular electrogram lead is in contact with blood.

84. The endovascular device of claim 83 wherein the endovascular electrogram lead is positioned at the elongate body distal end.

85. The endovascular device of claim 83 wherein the electrical sensing segment of an endovascular electrogram lead is positioned within 3 cm of the elongate body distal end.

86. The endovascular device of claim 83 wherein the electrical sensing segment of an endovascular electrogram lead is positioned within 3 cm of the non-imaging ultrasound transducer.

87. The endovascular device of claim 83 wherein the electrical sensing segment of an endovascular electrogram lead is positioned proximal to the non-imaging ultrasound transducer.

88. The endovascular device of claim 83 further comprising:

a second endovascular electrogram lead on the elongate body in a position that, when the endovascular device is in the vasculature, the second endovascular electrogram lead is in contact with blood.

89. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned about 5 cm from the endovascular electrogram lead.

90. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned about 5 cm from the elongate body distal end.

91. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned at a distance spaced apart from the endovascular electrogram lead so that the second endovascular electrogram lead detects a baseline electrogram signal when the endovascular electrogram lead is detecting a target electrogram signal.

92. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned at a distance related to the length of the superior vena cava such that when the endovascular electrogram lead is in the superior vena cava the second endovascular electrogram lead is outside of the superior vena cava.

93. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from the heart the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline ECG signal.

94. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from the brain the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline EEG signal.

95. The endovascular device of claim 88 wherein electrical sensing segment of the second endovascular electrogram lead is positioned such that when the electrical sensing segment of the endovascular electrogram lead is positioned to detect a targeted electrogram signal from a muscle the electrical sensing segment of the second endovascular electrogram lead is positioned to detect a comparison baseline EMG signal.

96. The endovascular device of claim 83 wherein the endovascular electrogram lead is moveable from a stowed condition within the elongate body and a deployed condition outside of the elongate body.

97. The endovascular device of claim 96 wherein the stowed endovascular electrogram lead curves the distal end of the endovascular device.

98. The endovascular device of claim 96 wherein when the endovascular electrogram lead is in the stowed condition the electrical sensing segment is positioned to detect an electrogram signal.

99. The endovascular device of claim 83 further comprising:

a steering element connected to the endovascular lead for directing the proximal end of the elongate body.

100. The endovascular device of claim 99 wherein the steering element provides torque to the elongate body distal end.

101. The endovascular device of claim 83 wherein the endovascular electrogram lead in use extends at least partially about the elongate body.

102. The endovascular device of claim 83 wherein the endovascular lead further comprises:

an atraumatic tip.

103. The endovascular device of claim 83 wherein the endovascular electrogram lead is formed from a shape memory alloy.

104. The endovascular device of claim 83 wherein the endovascular electrogram lead is adapted for use to move the ultrasound sensor away from a blood vessel wall.

105. The endovascular device of claim 83 wherein the endovascular device comprises a coated metal braided structure and a portion of the coating on the metal braided structure is removed and the exposed metal braided structure functions as an endovascular electrogram lead electrical sensing segment.

106. The endovascular device of claim 83 further comprising:

an atraumatic tip on the distal end of the endovascular device.

107. The endovascular device of claim 106 wherein the atraumatic tip comprises an ultrasound lens.

108. The endovascular device of claim 107 wherein the ultrasound lens is a divergent lens.

109. The endovascular device of claim 83 further comprising:

an opening in the elongate body; and

a lumen within the elongate body in communication with the opening and the elongate body proximal end.

110. The endovascular device of claim 83 further comprising an additional sensor on the endovascular device for measuring a physiological parameter.

111. The endovascular device of claim 110 wherein the additional sensor is an optical sensor.

112. The endovascular device of claim 111 wherein the physiological parameter is related to an optical property detected within the vasculature.

113. The endovascular device of claim 110 wherein the additional sensor is a pressure sensor.

114. The endovascular device of claim 113 wherein the physiological parameter is related to a pressure measurement obtained within the vasculature.

115. The endovascular device of claim 110 wherein the additional sensor is an acoustic sensor.

116. The endovascular device of claim 115 wherein the physiological parameter is related to an acoustic signal detected within the vasculature.

117. The endovascular access and guidance system of claim 83 wherein the elongate flexible member comprises a catheter.

118. The endovascular access and guidance system of claim 83 wherein the elongate flexible member comprises a guide wire.

119. The endovascular access and guidance system of claim 83 wherein the elongate flexible member comprises a stylet.

120. The endovascular access and guidance system of claim 83 wherein the elongate flexible member is adapted to deliver a therapy to the patient.

121. The endovascular access and guidance system of claim 83 wherein the elongate flexible member is adapted to provide endovascular access for another device.