Systems and methods for locating and defining a target location within a human body

• US 20040138555A1
• Filed: 12/23/2003
• Published: 07/15/2004
• Est. Priority Date: 05/14/1998
• Status: Active Grant

• Current Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Original Assignee: Varian Medical Systems Incorporated (Siemens AG)
• Inventors: Gilbert, Jon, Frecksa, Richard, Kinsella, Amy, Harry, Rosemary, Krag, David, Dimmer, Steve, Silverstein, Fred, Durbin, Duane, Meier, Eric, Moody, Trevor
• Granted Patent: US 8,452,375 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• 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 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/3941 Photoluminescent markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3958 : emitting a signal
• CPC Class Codes: A61B 2090/3975 : active
• CPC Class Codes: A61B 2090/3983 : Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/3995 : Multi-modality markers
• 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 34/74 : Manipulators with manual electric input means
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/90 : Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/92 : coded with colour
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders

Abstract

Systems and methods for locating and defining a target location within a human body. The system can include at least one marker, a probe, and a detector for use in locating the markers by providing information to a surgeon that is representative of changes in proximity between the probe and the marker. The marker can have various detection characteristics, e.g., gamma radiation, that are detectable by an associated probe and detector. The tissue volume is removed by manipulating a cutting tool based on the proximity information provided by the detector, which can be used by the surgeon to define the boundary of the tissue volume. The systems and methods of the invention are particularly useful in locating and then removing a tissue volume or other target location from amorphous, pliable tissue (e.g., breast tissue) or other body parts.

Claims

1. A system for locating a target location within a human body, comprising:

a first wireless implantable marker configured to be implanted within the human body at a location relative to the target location;

an instrument having a function-site and a first instrument marker connected to the instrument at a first predetermined site relative to the function-site;

a position detection system having a sensor that detects a position of the first wireless implantable marker relative to a reference location and a position of the first instrument marker relative to the reference location, wherein the position detecting system includes a computer that determines a relative position between the first wireless implantable marker and the first instrument marker based on the positions of the first wireless marker and the first instrument marker relative to the reference location; and

a user interface operatively coupled to the position detection system, the user interface having an indicator that denotes the position of the function-site of the instrument relative to the target location based on the relative position between the first wireless implantable marker and the first instrument marker.

2. The system of claim 1 wherein the user interface comprises a graphical display having a boundary relative to the first implantable marker, and wherein the boundary defines a margin relative to the target location.

3. The system of claim 1 wherein the user interface comprises a graphical display having a two-dimensional grid defining a plane and a boundary in the grid relative to the first implantable marker, and wherein the grid and the boundary define a margin relative to the target location in the plane.

4. The system of claim 1 wherein the user interface comprises a graphical display having a two-dimensional grid defining a plane, an elevation indicator providing an elevation of the function-site relative to the plane, and a boundary in the grid relative to the first implantable marker, and wherein the grid and the boundary define a margin relative to the target location in the plane.

5. The system of claim 1 wherein the elevation indicator comprises a numeric readout and/or a graphical representation.

6. The system of claim 1 wherein the marker comprises a radioactive isotope, and the position detection system comprises a device that detects a radiation level.

7. The system of claim 1 wherein the user interface comprises a graphical display having a three-dimensional representation that defines a margin relative to the target location.

8. The system of claim 1 wherein the user interface comprises a graphical display having a three-dimensional representation that defines an area relative to the function site of the instrument.

9. The system of claim 1 wherein the user interface comprises a graphical display having a first three-dimensional boundary relative to the first implantable marker and a second three-dimensional boundary relative to the second implantable marker, and wherein the first and second three-dimensional boundaries define a three-dimensional margin relative to the target location.

10. The system of claim 1 wherein the user interface comprises a graphical display having an opaque three-dimensional representation that defines a margin relative to the target location.

11. The system of claim 1 wherein the user interface comprises a graphical display having an opaque three-dimensional representation that defines a target an area relative to the function site of the instrument.

12. The system of claim 1 wherein the user interface comprises a graphical display having a first three-dimensional boundary relative to the first implantable marker and a second three-dimensional boundary relative to the second implantable marker, and wherein the first and second three-dimensional boundaries define a three-dimensional margin relative to the target location.

13. The system of claim 1 wherein:

the system further comprises a second wireless implantable marker configured to be implanted within the human body relative to the first implantable marker and the target location;

the position detection system also detects a position of the second wireless implantable marker relative to the reference location; and

the user interface provides an indicator of the position of the function-site of the instrument relative to the target location based on the relative position between the first wireless implantable marker and the first instrument marker, and/or a relative position between the second wireless implantable marker and the first instrument marker.

14. The system of claim 13 wherein the user interface comprises a graphical display having a first boundary relative to the first implantable marker and a second boundary relative to the second implantable marker, and wherein the first and second boundaries define a margin relative to the target location.

15. The system of claim 13 wherein the user interface comprises a graphical display having a two-dimensional grid defining a plane, a first boundary in the grid relative to the first implantable marker, and a second boundary in the grid relative to the second implantable marker, and wherein the first and second boundaries define a margin relative to the target location in the plane.

16. The system of claim 1 wherein:

the instrument further comprises a second instrument marker connected to the instrument and aligned with the first instrument marker along an alignment axis;

the position detection system also detects a position of the second instrument marker relative to the reference location; and

the user interface provides an indicator of the position and orientation of the function-site based on the positions of the first and second instrument markers relative to the reference location.

17. The system of claim 1 wherein the instrument further comprises a second instrument marker connected to the instrument and aligned with the first instrument marker and the function-site along an alignment axis.

18. The system of claim 1 wherein:

the instrument further comprises a second instrument marker connected to the instrument and aligned with the first instrument marker and the function-site along an alignment axis; and

the user interface comprises a graphical display having a two-dimensional grid defining a plane, an elevation indicator providing an elevation of the function-site relative to the plane, and an indicator showing the instrument as a point on the grid when the alignment axis is approximately normal to the plane or as a line when the alignment axis is not approximately normal to the plane.

19. The system of claim 18 wherein the grid and the boundary define a margin relative to the target location in the plane.

20. The system of claim 18 wherein the user interface includes a line that varies in length relative to degree that the alignment axis is not normal to the plane.

21. The system of claim 1 wherein:

the instrument further comprises a second instrument marker connected to the instrument at a second site and a third instrument marker connected to the instrument at a third site, wherein at least one of the second and third instrument markers are not aligned with the first instrument marker along an alignment axis;

the position detection system also detects a position of the second instrument marker and a position of the third instrument marker relative to the reference location; and

the user interface provides an indicator of the position and orientation of the function-site based on the positions of the first, second, and third instrument markers relative to the reference location.

22. The system of claim 1 wherein the instrument further comprises a wireless control for selecting a mode of operating the user interface.

23. The system of claim 22 wherein the wireless control comprises a cut-off switch that temporarily defeats a location functionality of the first instrument marker.

24. The system of claim 22 wherein:

the first instrument marker comprises a magnetic marker attached to the instrument; and

the wireless control comprises a magnetic shield that blocks a magnetic field of the magnetic marker to defeat location functionality of the first instrument marker.

25. The system of claim 22 wherein:

the first instrument marker comprises a mechanical resonator marker attached to the instrument; and

the wireless control comprises a dampening mechanism that cancels mechanical vibrations of the mechanical resonator to defeat location functionality of the first instrument marker.

26. The system of claim 22 wherein:

the wireless control comprises a slider marker that moves from a first position to a second position relative to the first instrument marker; and

the position detection system detects a position of the slider marker relative to the first instrument marker, and a functionality of the system is changed according to the relative position between the slider marker and the first instrument marker.

27. The system of claim 1 wherein the instrument further comprises a wireless control for selecting a mode of operating a component of the system.

28. The system of claim 27 wherein the wireless control comprises a cut-off switch that temporarily defeats a location functionality of the first instrument marker.

29. The system of claim 27 wherein:

the first instrument marker comprises a magnetic marker attached to the instrument; and

the wireless control comprises a magnetic shield that blocks a magnetic field of the magnetic marker to defeat location functionality of the first instrument marker.

30. The system of claim 27 wherein:

the first instrument marker comprises a mechanical resonator marker attached to the instrument; and

the wireless control comprises a dampening mechanism that cancels mechanical vibrations of the mechanical resonator to defeat location functionality of the first instrument marker.

31. The system of claim 1 wherein:

the instrument further comprises a second instrument marker along the alignment axis;

the user interface comprises a graphical display having a two-dimensional grid defining a plane, wherein the user interface continuously displays the two-dimensional plane orthogonal relative to the alignment axis.

32. The system of claim 1 wherein the instrument comprises a tissue stabilizer probe.

33. The system of claim 1 wherein the instrument comprises a cutting tool.

34. The system of claim 33 wherein the cutting tool comprises a scalpel.

35. The system of claim 33 wherein the cutting tool comprises a minimally invasive cutting device.

36. The system of claim 33 wherein the cutting tool comprises a bovie knife.

37. The system of claim 33 wherein the cutting tool comprises an ultrasonic cutting device.

38. The system of claim 16 wherein the cutting tool comprises scissors.

39. The system of claim 1 wherein the instrument comprises a radio frequency tissue ablation probe.

40. The system of claim 1 wherein the instrument comprises cryogenic tissue ablation probe.

41. The system of claim 1 wherein the instrument comprises interstitial laser probe.

42. The system of claim 1 wherein the instrument comprises a laproscopic probe.

43. The system of claim 1 wherein the instrument comprises a robotic surgery probe.

44. A system for locating a target location, comprising:

a first wireless implantable marker configured to be implanted into a body at a location relative to the target location, wherein the first wireless marker emits a wireless signal; and

a position detection system having an energy source that emits an excitation energy and a sensor that detects a position of the first wireless implantable marker relative to a reference location.

45. The system of claim 44, further comprising a user interface coupled to the position detection system, wherein the user interface includes an indicator of a boundary relative to the first wireless marker defining a desired margin around the target location.

46. The system of claim 44, further comprising a user interface coupled to the position detection system, wherein the user interface includes an indicator of a first target position relative to the first wireless marker defining the target location.

47. A wireless marker for implantation, comprising:

a biocompatible casing configured to be implanted into a human body relative to a target location within the human body;

a signal element in the casing, the signal element being configured to emit a response energy in reaction to an excitation energy; and

a fastener configured to hold the wireless marker at a reference location in a human body relative to the target location within the human body

48. The wireless marker of claim 47 wherein the signal element comprises an electronic circuit resonator.

49. The wireless marker of claim 47 wherein the signal element comprises a magnetic resonator.

50. The wireless marker of claim 47 wherein the signal element comprises a radio frequency marker.

51. The wireless marker of claim 47 wherein the signal element comprises a mechanical resonator.

52. The wireless marker of claim 47 wherein the signal element comprises a magnet.

53. The wireless marker of claim 47 wherein the signal element comprises a fluorescent material.

54. The wireless marker of claim 47 wherein the fastener comprises a protrusion integral with the casing.

55. The wireless marker of claim 47 wherein the fastener comprises an adhesive material.

56. The wireless marker of claim 47 wherein the fastener comprises a protein that binds and/or adheres to tissue.

57. The wireless marker of claim 47 wherein the fastener comprises a polymer that binds and/or adheres to tissue.

58. The wireless marker of claim 47 wherein the fastener comprises a biasing member that is biased to expand from a stored position to a deployed position.

59. The wireless marker of claim 47 wherein the fastener comprises a biasing member that is biased to contract from a stored position to a deployed position.

60. The wireless marker of claim 47 wherein the fastener is a spring material element that forms a loop to grasp tissue in a deployed position.

61. A wireless marker for implantation, comprising:

a biocompatible casing configured to be implanted into a human body relative to a target location within the human body; and

an identifier on and/or in the casing that can be observed by an imaging system to distinguish the casing from other casings that have been implanted into the human body.

62. The wireless marker of claim 61 wherein the identifier comprises metal bands around the casing.

63. The wireless marker of claim 61 wherein the identifier comprises a shape of the casing.

64. The wireless marker of claim 61, further comprising a fastener configured to hold the wireless marker at a reference location relative to the target location, and wherein the identifier comprises a shape of the fastener.

65. A wireless marker for implantation, comprising:

a biocompatible casing configured to be implanted into a human body relative to a target location within the human body; and

an identifier on and/or in the casing that can be observed visually to distinguish the casing from other casings that have been implanted into the human body.

66. The wireless marker of claim 65 wherein the identifier comprises metal bands around the casing.

67. The wireless marker of claim 65 wherein the identifier comprises a shape of the casing.

68. The wireless marker of claim 65, further comprising a fastener configured to hold the wireless marker at a reference location relative to the target location, and wherein the identifier comprises a shape of the fastener.

69. The wireless marker of claim 65 wherein the identifier comprises unique colors of the wireless marker casing.

70. An instrument for manipulation within a human, comprising:

a handle;

a function-site coupled to the handle, the function-site being aligned with an alignment axis;

a first instrument marker along the alignment axis; and

a second instrument marker along the alignment axis.

71. An instrument for manipulation within a human, comprising:

a handle;

a function-site coupled to the handle, the function-site being aligned with an alignment axis; and

a first wireless instrument marker along the alignment axis, wherein the first wireless instrument marker emits a wireless signal that can be detected by a position detection system to determine a position of the first wireless instrument marker relative to a reference location.

72. An instrument for manipulation within a human, comprising:

a handle;

a function-site coupled to the handle, the function-site being aligned with an alignment axis;

a first wireless instrument marker along the alignment axis, wherein the first wireless instrument marker emits a wireless signal that can be detected by a position detection system to determine a position of the first wireless instrument marker relative to a reference location; and

a user interface attached to the instrument and coupled to the detection system, wherein the user interface includes an indicator of a relative position between the function-site and a target location within the human.

73. A system for locating a target location within a human body, comprising:

an instrument having a handle, a function-site coupled to the handle, and at least one instrument maker attached to the instrument at a predetermined location relative to the function-site; and

a detection system that detects a characteristic of the instrument marker and determines a configuration of the instrument and/or the function-site.

74. The system of claim 73 wherein the instrument marker configuration comprises a location of the instrument marker.

75. The system of claim 73 wherein the instrument marker configuration comprises a marker resonator frequency.

76. A method of providing information for a procedure in which a first wireless implantable marker is implanted in a human body relative to a target location and an instrument marker is coupled to an instrument at a predetermined site relative to a function-site on the instrument, the method comprising:

emitting a resonating energy from the first wireless implanted marker;

sensing a location of the first wireless marker relative to a reference location;

sensing a location of the instrument marker relative to the reference location;

correlating a relative position between the first wireless marker and the instrument marker based on the sensed locations; and

determining a relative position between the function-site and the first wireless implanted marker by adding together the relative position between the first wireless marker and the target location, a relative position between the instrument marker and the function-site, and the relative position between the first wireless marker and the instrument marker.

77. The method of claim 76, further comprising:

comparing the position of the function-site to the target location; and

providing an indication of the position of the function-site relative to the target location.

78. The method of claim 76 wherein, if the first wireless marker is implanted in the target location, then the method further comprises generating a virtual margin to extend at least partially around the marker.

79. The method of claim 76 wherein, if the first wireless marker is implanted adjacent to the target location such that the marker in offset from the target location, and the method further comprises generating a virtual margin to extend at least partially around the target location.

80. A method of treating a target location within a human body, comprising:

exciting a wireless marker implanted in the body by emitting an excitation energy in a manner that causes the marker to emit a response energy;

sensing the response energy; and

determining a position of the wireless marker relative to a reference location based on the sensed response energy.

81. The method of claim 80, further comprising directing an intra-operative radiation energy relative to the determined position of the wireless marker.

82. The method of claim 80, further comprising monitoring an intra-operative radiation energy relative to the determined position of the wireless marker.

83. The method of claim 80, further comprising directing an external beam radiation energy relative to the determined position of the wireless marker.

84. The method of claim 80, further comprising monitoring an external beam radiation energy relative to the determined position of the wireless marker.

85. The method of claim 80, further comprising directing a brachy radiation energy relative to the determined position of the wireless marker.

86. The method of claim 80, further comprising monitoring brachy radiation energy relative to the determined position of the wireless marker.