DEVICES, SYSTEMS AND METHODS FOR ENHANCED VISUALIZATION OF THE ANATOMY OF A PATIENT

• US 20110251482A1
• Filed: 10/15/2010
• Published: 10/13/2011
• Est. Priority Date: 10/29/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: ROX Medical, Inc.
• Inventors: Kellerman, Brad, Flaherty, J. Christopher
• Application Number:
  US12/905,412
• Publication Number:
  US 20110251482A1
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0841 for locating instruments

Abstract

Devices, systems and methods are described for visualizing the anatomy of a patient. An expanding portion is configured to expand towards the tissue walls of a body space and be visible with one or more visualization instruments. Systems and methods are described which advance a probe from a first vessel toward a target in a second vessel.

Claims

1. An anatomy visualization device comprising:

an elongate filament with a proximal end, a distal end, and an expandable portion, said expandable portion configured for insertion into a body space of a patient;

wherein the body space is surrounded by one or more tissue walls; and

wherein the expandable portion is configured to radially expand toward the one or more tissue walls, said expandable portion further configured to be visualized while expanded toward the one or more tissue walls.

2. The device of claim 1 wherein the device provides real time visualization of the body space.

3. The device of claim 1 wherein the device is configured to provide information selected from the group consisting of:

vessel geometry information such as diameter, curvilinear shape and other vessel geometry information useful in an angioplasty, stenting, atherectomy and other vessel diagnostic or therapeutic procedures;

fistula and intended fistula site information such as information regarding a preferred location for a fistula to be created and/or a needle or other probe to be advanced from a first vessel to a second vessel such as to a create a fistula during a TIPS procedure or a cardiopulmonary therapy procedure.

4. The device of claim 1 further comprising a visualization instrument configured to visualize the expanded portion and selected from the group consisting of:

a fluoroscope or other x-ray visualization apparatus;

an ultrasound visualization apparatus;

a Ct-scanner;

a magnetic resonance imaging apparatus (MRI);

a PET scanner;

an electromagnetic (EM) field detection apparatus; and

combinations thereof.

5. The device of claim 1 wherein the elongate filament is a flexible filament.

6. The device of claim 1 wherein the elongate filament has a guidewire construction.

7. The device of claim 1 wherein the elongate filament is constructed of materials selected from the group consisting of:

Nitinol;

stainless steel;

Tungsten, CoCr a polymer or polymer blend; and

combinations thereof.

8. The device of claim 1 wherein the elongate filament includes one or more of a hydrophobic coating;

a hydrophilic coating;

a PTFE coating;

a PTFE covering; and

combinations thereof.

9. The device of claim 1 wherein the elongate filament includes a proximal end and a distal end with a lumen from said proximal end to a location at or near said distal end.

10. The device of claim 9 further comprising a mandrel configured to be inserted in the lumen.

11. The device of claim 10 wherein expandable portion is configured to radially expand when the mandrel is inserted into the lumen.

12. The device of claim 1 wherein the expandable portion includes a target portion, said target portion configured to be placed at a target location.

13. The device of claim 12 wherein the target location in an anatomical location selected for a penetrating probe to advance into.

14. The device of claim 12 wherein the target portion radially expands toward the tissue walls.

15. The device of claim 12 wherein the target portion is a spiral geometry.

16. The device of claim 15 wherein the spiral has a diameter range of approximately 2 mm to 25 mm.

17. The device of claim 16 wherein the spiral has a diameter range of 8 mm to 10 mm.

18. The device of claim 15 wherein the filament includes a straight portion distal to the target portion.

19. The device of claim 18 wherein the straight portion has a length of 4 cm to 7 cm.

20. The device of claim 1 wherein the expandable portion is configured to transition from a constrained condition to a radially expanded condition.

21. The device of claim 20 further comprising a sheath with a distal end;

wherein the sheath is configured to slidingly receive the expandable portion; and

wherein the expandable portion transitions from the constrained condition to the radially expanded condition as it exits the distal end of the sheath.

22. The device of claim 21 wherein the expandable portion comprises a single filament which radially expands to a helical geometry.

23. The device of claim 21 wherein the expandable portion comprises at least two filaments, each comprising a proximal end and a distal end, wherein said filament distal ends extend radially out when exiting the sheath distal end.

24. The device of claim 23 wherein the expandable portion further comprises a band surrounding said filament proximal ends.

25. The device of claim 23 wherein the tines are cut from a cylindrical tube shaped into the expandable portion.

26. The device of claim 1 wherein the expandable portion is configured to approximate the tissue walls of the body space when radially expanded.

27. The device of claim 1 wherein the expandable portion is elastically biased in the radially expanded condition.

28. The device of claim 1 wherein the expandable portion is temperature activated to radially expand.

29. The device of claim 28 wherein the temperature activation occurs at body temperature.

30. The device of claim 1 wherein the expandable portion is mechanically activated to radially expand.

31. The device of claim 30 further comprising a mandrel, wherein the mechanical activation is achieved when the mandrel is inserted within the expandable portion.

32. The device of claim 1 wherein the expandable portion is in a helical geometry when radially expanded.

33. The device of claim 32 wherein the expandable portion transitions from a linear or near linear geometry to said helical geometry.

34. The device of claim 32 wherein the helical geometry includes more than 360°

of helix.

35. The device of claim 32 wherein the helical geometry has a diameter of at least 2 mm.

36. The device of claim 35 wherein the helical geometry has a diameter of approximately 8 mm to 10 mm.

37. The device of claim 32 wherein the helical geometry has a diameter between 2 mm and 25 mm.

38. The device of claim 32 wherein the helical geometry has a length of 10 mm to 60 mm.

39. The device of claim 32 wherein the helical geometry has a length of approximately 30 mm.

40. The device of claim 1 wherein the expandable portion is configured to transform from an approximately linear geometry to a helical geometry.

41. The device of claim 40 further comprising a sheath with a distal end;

wherein the sheath is configured to slidingly receive the expandable portion; and

wherein the expandable portion transitions from the approximately linear geometry to the helical geometry as it exits the distal end of the sheath.

42. The device of claim 1 wherein the expandable portion comprises an expandable basket or an expandable cage.

43. The device of claim 1 wherein the expandable portion is electromagnetically expandable.

44. The device of claim 1 wherein the expandable portion is radiopaque.

45. The device of claim 1 wherein the expandable portion includes a marker selected from the group consisting of:

a radiopaque marker;

an electromagnetic marker;

a magnetic marker;

an ultrasonically reflective marker; and

combinations thereof.

46. The device of claim 1 wherein said device is further configured to provide radial force at the expandable portion.

47. The device of claim 46 wherein the expandable portion is configured to prevent collapse of the tissue walls.

48. The device of claim 1 wherein the expandable portion is configured to radially collapse.

49. The device of claim 48 wherein the expandable portion is configured to be removed from the patient after said radial collapse.

50. The device of claim 1 wherein the tissue walls are vessel walls.

51. The device of claim 50 wherein the vessel walls are walls of an artery or vein.

52. The device of claim 1 wherein the elongate filament is configured to be inserted percutaneously.

53. The device of claim 52 wherein the insertion is performed through a guide catheter.

54. The device of claim 1 wherein the elongate filament is configured to be inserted in a surgical procedure.

55. The device of claim 54 wherein the surgical procedure is a minimally invasive surgical procedure.

56. The device of claim 1 wherein the filament is configured for insertion into a body space selected from the group consisting of:

blood vessel lumen;

chamber of the heart;

stomach;

urethra;

body cavity; and

billary duct.

57. The device of claim 1 further comprising at least one marker.

58. The device of claim 57 wherein the marker is selected from the group consisting of:

radiopaque;

ultrasonic;

electromagnetic; and

combinations thereof.

59. The device of claim 57 wherein the marker is included in the expandable portion.

60. The device of claim 57 wherein the length of the marker is used to measure a portion of the patient'"'"'s anatomy.

61. The device of claim 57 comprising a first marker and a second marker, wherein the distance between the first marker and second marker is used to measure a portion of the patient'"'"'s anatomy.

62. The device of claim 1 wherein said device includes a proximal end, a distal end, and a handle attached to the proximal end, said handle including at least one control.

63. The device of claim 62 wherein the at least one control is configured to:

advance or retract a filament;

cause radial expansion or contraction;

deliver energy such as energy delivered to a fistula site;

apply positive pressure or vacuum; and

combinations thereof.

64. The device of claim 62 where the handle includes one or more markings.

65. The device of claim 64 wherein the markings are selected from the group consisting of:

visual markings;

tactile markings; and

combinations thereof.

66. The device of claim 64 wherein the markings are configured to provide information related to:

advancement or retraction of a filament;

amount of expansion of a visualization device expandable portion such as the amount of radial expansion;

amount of force applied to tissue walls by a visualization device;

amount of advancement or retraction of a probe such as a needle; and

combinations thereof.

67. A system for advancing a probe from a first vessel into a second vessel at a target location in a patient comprising:

a probe advancement device comprising;

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

an advanceable probe;

wherein the distal end is configured to be placed intraluminally in a first vessel;

an anatomy visualization device of claim 1 configured to be placed intraluminally in a second vessel;

wherein the probe is configured to be advanced from the first vessel toward the target portion of the anatomy visualization device and into the second vessel.

68. The system of claim 67 wherein the probe is configured to exit the distal end of the elongate tube.

69. The system of claim 67 wherein the probe is configured to exit at a location proximal to the distal end of the elongate tube.

70. The system of claim 67 wherein the elongate tube includes a lumen from the proximal end to distal end, and the probe is slidingly received by said lumen.

71. The system of claim 67 wherein the probe is a hollow core needle.

72. The system of claim 71 further comprising a guidewire with a distal end, said system configured to advance said distal end through the probe into the second vessel.

73. The system of claim 72 wherein the probe advancement device is configured to be removed leaving the guidewire traversing the first vessel into the second vessel.

74. The system of claim 73 wherein the guidewire is configured to allow a fistula creation device pass over said guidewire and expand to create a fistula between the first vessel and the second vessel.

75. The system of claim 71 further comprising a catheter with a distal end, said catheter distal end configured to be advanced through the probe into the second vessel.

76. The system of claim 71 further comprising an agent, said system configured to deliver the agent through the probe into the second vessel.

77. The system of claim 67 wherein the probe includes a radiation delivery element.

78. The system of claim 67 wherein the probe comprises a guidewire.

79. The system of claim 67 wherein the probe comprises a catheter.

80. The system of claim 79 wherein the probe further comprises a mandrel slidingly received by the catheter, said probe including a tip sharpened to penetrate from the first vessel to the second vessel.

81. The system of claim 67 wherein the probe advancement device further comprises a handle on the proximal end of the elongate tube.

82. The system of claim 81 wherein the handle includes a control configured to advance the probe.

83. The system of claim 81 wherein the handle includes one or more markings configured to illustrate the position of the probe.

84. The system of claim 67 wherein the first vessel is an artery.

85. The system of claim 84 wherein the second vessel is a vein.

86. The system of claim 67 wherein the second vessel is an artery.

87. The system of claim 86 wherein the first vessel is a vein.

88. The system of claim 67 wherein the first and second vessels are arteries.

89. The system of claim 67 wherein the first and second vessels are veins.

90. The system of claim 67 wherein the first vessel or the second vessel is an artery selected from the group consisting of:

femoral artery;

internal iliac artery;

external iliac artery;

subclavian artery; and

the aorta.

91. The system of claim 67 wherein the first vessel or the second vessel is a vein selected from the group consisting of:

femoral vein;

internal iliac vein;

external iliac vein;

subclavian vein; and

the inferior vena cava.

92. The system of claim 67 wherein the target location is an intended anatomical location for a fistula to be created.

93. The system of claim 92 wherein the fistula is a therapeutic fistula.

94. The system of claim 93 wherein the therapy is tended to treat a patient condition selected from the group consisting of:

COPD;

congestive heart failure;

heart failure;

hypertension;

hypotension;

coronary artery disease;

respiratory failure;

lung fibrosis;

adult respiratory distress syndrome (ARDS);

chronic bronchitis;

emphysema;

cystic fibrosis;

cystic lung disease;

chronic asthma; and

combinations thereof.

95. The system of claim 92 wherein the fistula is created to support dialysis therapy.

96. The system of claim 67 wherein the target location is an intended anatomical location for drug to be delivered.

97. The system of claim 96 wherein the drug is to be delivered into the second vessel.

98. The system of claim 67 further comprising a dilation device configured to expand tissue at the target location.

99. The system of claim 98 wherein the dilation device is integral to the needle advancement assembly.

100. The system of claim 67 further comprising an anastomotic clip to be deployed at the target location.

101. The system of claim 100 wherein the probe advancement device is configured to deliver the anastomotic clip.

102. The system of claim 67 further comprising a probe capture device configured to mechanically attach to at least a portion of the probe when said portion is in the second vessel.

103. The system of claim 102 wherein the probe is a guidewire.

104. The system of claim 102 wherein the probe capture device can move the probe proximally in the second vessel.

105. The system of claim 102 wherein the probe capture device can move the probe distally in the second vessel.

114. A method of visualizing the anatomy of a patient comprising:

inserting the expandable portion of the device of claim 1 into a body space of the patient; and

radially expanding the expandable portion of the device.

106. A method of advancing a probe from a first vessel to a second vessel at a target location within a patient, comprising:

placing a probe advancement device into the first vessel, said probe advancement device comprising;

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

an advanceable probe;

placing an anatomy visualization device into the second vessel, said anatomy visualization device comprising a target portion;

intraluminally advancing the anatomy visualization device target portion to a target site of the patient'"'"'s anatomy;

transluminally advancing the probe advancement device probe toward said target portion and into the second vessel.

107. The method of claim 106 further comprising intraluminally advancing the probe advancement device in the first vessel, prior to the transluminal advancement of the probe.

108. The method of claim 106 further comprising retracting the anatomy visualization device in the second vessel.

109. The method of claim 108 further comprising advancing a device through the probe into the second vessel.

110. The method of claim 106 wherein the anatomy visualization device includes a capture device.

111. The method of claim 110 wherein the capture device is a compressible basket.

112. The method of claim 110 further comprising capturing the probe with the capture device.

113. The method of claim 110 further comprising advancing a guidewire through the probe and capturing the guidewire with the capture device.