Vessel Position and Configuration Imaging Apparatus and Methods

• US 20080171934A1
• Filed: 01/12/2007
• Published: 07/17/2008
• Est. Priority Date: 01/12/2007
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Gardeski, Ken, Simon, David, Bruszewski, Walter, Greenan, Trevor, Yamasaki, Dwayne S.
• Granted Patent: US 8,473,030 B2
• Time in Patent Office: Days
• US Class Current: 600/411
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2562/043 in a linear array
• 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 5/06 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

One or more markers or sensors are positioned in the vasculature of a patient to facilitate determining the location, configuration, and/or orientation of a vessel or certain aspects thereof (e.g., a branch vessel), determining the location, configuration and/or orientation of a endovascular devices prior to and during prosthesis deployment as well as the relative position of portions of the vasculature and devices, generating an image of a virtual model of a portion of one or more vessels (e.g., branch vessels) or devices, and/or formation of one or more openings in a tubular prosthesis in situ to allow branch vessel perfusion when the prosthesis is placed over one or more branch vessels in a patient (e.g., when an aortic abdominal artery stent-graft is fixed to the aorta superior to the renal artery ostia).

Claims

1. A method of real time monitoring the position of a portion of a second vessel, which branches from a first vessel in a human patient comprising:

acquiring a multi-dimensional data set of a portion of first and second vessels where the second vessel branches from the first vessel;

securing at least one marker to one of the first and second vessels in the vicinity of where the second vessel branches from the first vessel;

determining the position of the marker in real time; and

updating the position of a portion of the three-dimensional data set relative to the juncture between the first and second vessels in real time based on change in position of the marker.

2. The method of claim 1 wherein acquiring the multi-dimensional data set comprises acquiring a three-dimensional data set.

3. The method of claim 1 including displaying the updated position of a portion of the three-dimensional data set in real time.

4. The method of claim 3 wherein displaying the updated position of a portion of the three-dimensional data set comprises displaying an image of the second vessel ostium in real time.

59. The method of claim 1 including acquiring a three-dimensional data set of the portion of the first vessel and second vessels prior to acquisition of the multi-dimensional data set, registering the data sets and associating the marker position with one of the data sets.

60. The method of claim 59 wherein acquiring the multi-dimensional data set comprises acquiring a two-dimensional data set.

61. The method of claim 59 wherein acquiring the multi-dimensional data set comprises acquiring a three-dimensional data set.

5. A method of real time monitoring the position of a portion of a second vessel, which branches from a first vessel in a human patient comprising:

positioning an electromagnetic coil in a second vessel, which branches from a first vessel in a human patient;

generating electromagnetic fields about the coil; and

processing signals from the coil to determine the position of the coil.

6. The method of claim 5 wherein a plurality of electromagnetic coils are positioned in the second vessel and signals from each coil are processed to determine the position of each coil.

7. The method of claim 5 further including deploying a stent-graft in the second vessel based on the determined positions.

8. A method of real time virtual three-dimensional modeling of a vessel comprising:

positioning each of a plurality of electromagnetic coils against the inner wall of a vessel;

generating electromagnetic fields about the coils; and

processing signals from the coils to create a virtual three-dimensional model of a portion of the vessel inner wall.

9. The method of claim 8 wherein the coils are oriented in a helical array.

10. The method of claim 9 wherein about 8-10 coils are oriented in the helical array.

11. The method of claim 8 wherein the coils are positioned in a vessel that branches from the aorta.

12. The method of claim 8 wherein the coils are oriented in a generally circular array.

13. The method of claim 12 wherein the coils are positioned in a vessel that branches from the aorta.

14. The method of claim 8 wherein the coils are positioned in a renal artery.

15. A method of generating a representation generally along the central axis of a portion of a vessel comprising:

positioning a plurality of markers in a vessel in a configuration that has an axis that extends generally along the central axis of a portion of the vessel;

subjecting the markers to non-ionizing radiation energy; and

generating a virtual three-dimensional model of the configuration axis that extends generally along the central axis of a portion of the vessel based on the markers'"'"' response to or effect on the non-ionizing radiation energy.

16. A method of generating a representation generally along the central axis of a portion of a vessel comprising:

positioning a plurality of electromagnetic coils in a vessel in a configuration that has an axis that extends generally along the central axis of a portion of the vessel;

generating electromagnetic fields about the markers; and

processing signals from the coils to create a virtual three-dimensional model of the configuration axis that extends generally along the central axis of a portion of the vessel.

17. The method of claim 16 wherein the coils are positioned in a helical array having central axis that that extends generally along the central axis of a portion of the vessel.

18. The method of claim 16 wherein the coils are positioned in a generally circular configuration having a center axis that extends generally along the central axis of a portion of the vessel.

19. The method of claim 16 wherein the antenna coils are positioned in a generally straight line that extends generally along the central axis of a portion of the vessel.

20. A method of forming an opening in a prosthesis, having a tubular wall, in vivo, comprising:

forming a target in a second vessel that branches from a first vessel in a human patient;

endovascularly positioning a prosthesis having a tubular wall in the second passageway such that it overlaps the opening of the second vessel that opens to the first vessel;

positioning a puncture device, having a distal end portion and a proximal end portion, in the prosthesis;

aligning the distal end portion of the puncture device with the target; and

advancing the distal end portion of the puncture device through a portion of the tubular wall toward the target.

21. A method of forming an opening in a prosthesis, having a tubular wall, in vivo, comprising:

positioning at least one marker in a second vessel that branches from a first vessel in a human patient;

endovascularly positioning a tubular prosthesis in the first vessel such that it overlaps the opening of the second vessel that opens to the first vessel;

subjecting the marker to non-ionizing radiation energy;

determining the position of the marker based on its response to or effect on the non-ionizing radiation energy; and

forming an opening in the prosthesis adjacent to the second vessel opening based on the determined position.

22. A method of forming an opening in a prosthesis, having a tubular wall, in vivo, comprising:

positioning at least one electromagnetic coil in a second vessel that branches from a first vessel in a human patient;

endovascularly positioning a tubular prosthesis in the first vessel such that it overlaps the opening of the second vessel that opens to the first vessel;

generating an electromagnetic field about the coil;

processing signals from the coil to determine the position of the coil; and

forming an opening in the prosthesis adjacent to the second vessel opening based on the determined position.

23. The method of claim 22 wherein a plurality coils are positioned in the second vessel and signals from each coil are processed to determine the position of each coil, and the position of the opening formed in the prosthesis adjacent to the first passageway opening is based on the determined positions.

24. The method of claim 23 wherein the plurality of coils are oriented in a helical array and positioned against the inner wall of the first vessel, the electromagnetic fields are generated about the array of coils, and signals from the coils are processed to create a virtual three-dimensional model of a portion of the second vessel inner wall.

25. The method of claim 24 wherein about 8-10 coils are oriented in the helical array.

26. The method of claim 22 including positioning a plurality of electromagnetic coils in the second vessel in a configuration that has an axis that extends generally along the central axis of a portion of the second vessel;

introducing a puncture device having a distal end portion having a second axis and a proximal end portion in the prosthesis, aligning the axis that extends generally along the central axis of a portion of the second vessel and the second axes such that they are substantially coaxial, and advancing the distal end portion of the puncture device through a portion of the tubular wall of the prosthesis while maintaining the axes substantially coaxial.

27. The method of claim 26 wherein the plurality of coils are arranged in a helical array.

28. The method of claim 26 wherein the plurality of coils are oriented in a generally circular array.

29. The method of claim 22 including positioning a plurality of electromagnetic coils in the second vessel in a configuration that has a first axis that extends generally along the central axis of a portion of the second vessel;

introducing a puncture device in the first vessel where the puncture device has a distal end portion and a proximal end portion and the distal end portion has a pair of antenna coils aligned with the longitudinal axis of the distal end portion, generating electromagnetic fields about the coils in the second vessel and the puncture device coils, processing signals from the puncture device coils and second vessel coils and generating a three-dimensional model of the longitudinal axis of the puncture device and the first axis, aligning the puncture device distal end portion axis with the first axis and advancing the distal end portion of the puncture device through a portion of the tubular wall while maintaining the axes substantially aligned.

30. The method of claim 29 wherein the plurality of coils are arranged in a helical array.

31. The method of claim 29 wherein the plurality of coils are oriented in a generally circular array.

32. The method of claim 22 wherein the first vessel branches from the aorta.

33. The method of claim 32 wherein the first and second branch passageways are renal arteries.

34. An angiographic catheter for locating a branch vessel comprising an elongated member having a perforated distal end portion and a proximal end portion and being adapted for endovascular advancement through a portion of a patient'"'"'s vasculature, at least one electromagnetic coil secured to said distal end portion for transmitting signals to signal processing apparatus when exposed to electromagnetic fields.

35. An endovascular system for locating a branch vessel position comprising:

a first elongated member having a distal end portion and a proximal end portion and being adapted for endovascular advancement through a portion of a patient'"'"'s vasculature;

at least one sensing coil secured to said distal end portion;

a second elongated member having a distal end portion and a proximal end portion and being adapted for endovascular advancement through a portion of a patient'"'"'s vasculature; and

at least one sensing coil being secured to said second elongated member distal end portion.

36. The system of claim 35 wherein said elongated members are steerable catheters.

37. The system of claim 35 wherein said elongated members are microcatheters.

38. The system of claim 35 wherein said elongated members are guidewires.

39. The system of claim 35 wherein at least one of said elongated members has about a 90 degree preshaped bend formed in said distal portion proximal to said coil.

40. The system of claim 35 wherein the distal end portion of at least one of said elongated members has a memory set configuration.

41. The system of claim 40 wherein said memory set configuration is angular.

42. The system of claim 40 wherein said memory set configuration is a helical configuration and said at least one of said elongated members has a plurality of coils arranged in a helical array along said member.

43. The system of claim 40 wherein said distal portion has a plurality of arms arranged about an axis where said arms are urged toward one another in a first deformed state and tend to move away from said first deformed state toward said memory set configuration.

44. An endovascular device comprising:

an elongated member having a distal end portion and a proximal end portion and being adapted for endovascular advancement through a portion of a patient'"'"'s vasculature, said distal end portion having a memory set configuration and a deformed configuration; and

a sheath slidably disposed about said distal end portion and restraining said distal end portion in said deformed state, said sheath being movable to expose said distal end portion and allow said distal end portion to move toward said memory set configuration.

45. The device of claim 44 including at least one trackable marker coupled to said elongated member distal end portion.

46. The device of claim 44 wherein said memory set configuration is a helical configuration.

47. The device of claim 46 including a plurality of markers coupled to said elongated member distal end portion and arranged in a helical array.

48. The device of claim 47 wherein said markers are electromagnetic coils.

49. The device of claim 44 wherein said distal portion has a plurality of arms arranged about an axis, said arms are urged toward one another in a first deformed state and tend to move away from said first deformed state toward said memory set configuration.

50. The device of claim 49 including a plurality of markers coupled to said plurality of arms.

51. The device of claim 50 wherein said markers are electromagnetic coils.

52. A prosthesis delivery system comprising:

a prosthesis delivery catheter;

a tubular prosthesis disposed in said delivery catheter;

an elongated member having a distal end portion and a proximal end portion and being adapted for endovascular advancement through a portion of a patient'"'"'s vasculature;

a plurality of markers arranged along said distal end portion;

a steerable puncture catheter having a proximal end portion and a distal end portion, and a piercing end adapted to pierce graft material; and

a plurality of markers attached to said distal end portion of said steerable catheter.

53. The system of claim 52 wherein said markers are electromagnetic coils.

54. The system of claim 52 further including a sheath slidably disposed about said distal end portion of said elongated member and wherein said distal end portion of said elongated member has a memory set configuration and a deformed configuration, said sheath restraining said distal end portion in said deformed state and being retractable to expose said distal end portion and allow said distal end portion to move toward said memory set configuration.

55. The system of claim 54 wherein said memory set configuration is a helical configuration.

56. The system of claim 54 wherein said distal portion has a plurality of arms arranged about an axis, said arms are urged toward one another in said deformed state and tend to move away from said deformed state toward said memory set configuration.

57. Prosthesis delivery apparatus comprising:

a guidewire adapted for endovascular delivery in a patient; and

an electromagnetic coil secured to said guidewire.

58. The apparatus of claim 57 wherein said guidewire has a distal end portion and a proximal end portion, said electromagnetic coil being secured to said distal end portion.