Open field system for magnetic surgery

• US 6,241,671 B1
• Filed: 12/14/1998
• Issued: 06/05/2001
• Est. Priority Date: 11/03/1998
• Status: Expired due to Term

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Wolfersberger, Charles, Creighton, Francis M., Ritter, Rogers C., Blume, Walter M., Garibaldi, Jeffrey M., Werp, Peter R., Hogg, Bevil J.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/211,723
• Time in Patent Office: 904 Days
• Field of Search: 600/407, 600/410, 600/434, 600/424, 600/427, 600/409, 128/898, 128/899, 361/141, 335/177, 335/207, 335/216, 335/296, 335/297, 335/298, 324/307, 324/309, 324/318, 324/319
• US Class Current: 600/427
• CPC Class Codes: A61B 2034/733 arranged only on one side of the patient, e.g. under a table
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61B 6/0487 Motor-assisted positioning
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm

Abstract

A system of navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising magnets, and preferably electromagnets, arranged to provide a magnetic field sufficient to navigate the magnetic medical device within the operating region. There are preferably three magnetic coils arranged in mutually perpendicular planes such that their axes intersect in the operating region. The magnetic coils are sized and arranged so that a patient can easily access the operating region to allow virtually any portion of the patient to be positioned within the operating region. The openness of the magnetic system allows access to the operating region by a bi-planer imaging system.

Claims

1. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

at least three magnets configured and arranged in a hemispherically shaped shell to provide a magnetic field effective within the operating region to navigate the magnetic medical device within the operating region.

2. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

at least three magnet coils configured and arranged in an open concave shell to provide a magnetic field effective within the operating region to navigate the magnetic medical device within the operating region.

3. The system according to claim 2 wherein the shell has an opening through which a portion of the patient can extend into the operating region without passing though one of the coils.

4. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

a single magnet arranged and configured to provide a magnetic field along at least one of a plurality of oblique axes extending through the operating region, one or more magnets arranged and configured to provide a magnetic field along each of the other of said oblique axes, said magnetic fields being effective to controllably navigate the medical device within substantially the entirety of the operating region.

5. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

a plurality of magnet coils mounted within one or more supports, said magnet coils being effective to controllably navigate the medical device within substantially the entirety of the operating region, said operating region being positioned so that said part of the patient may be located within the operating region without passing through any of said magnet coils.

6. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

a plurality of magnets effective for creating a magnetic field sufficient to navigate said medical device within said operating region, said plurality of magnets being generally aligned along a plurality of oblique axes with only a single one of said magnets being aligned along one of said axes, and one or more magnets being aligned along the others of said axes.

7. The system according to claim 6 wherein the axes extend through the operating region of the system.

8. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

a plurality of magnets mounted within one or more supports, said magnets being effective to controllably navigate the medical device within substantially the entirety of the operating region, a patient support for supporting a patient intended to be located within said operating region, said patient support being moveable with respect to said supports for said magnets, said patient support being positioned with respect to said magnets so that as said patient support is advanced toward said magnets, said patient is moved into said operating region before said patient passes through the bore of any magnet.

9. A system for navigating a magnetic medical device within that part of a patient located within an operating region, the system comprising:

a plurality of navigating magnets effective to controllably navigate the medical device with substantially the entirety of the operating region, and

a patient support for moving the patient into the operating region of the system, only a single one of said magnets having its central axis generally aligned with the direction of movement of the patient support, and the others of said magnets being aligned with a plurality of oblique axes extending through the operating region.

10. A system for navigating a magnetic medical device within that part of a patient located within an operating region of the system, the system comprising:

a total of three navigating magnets configured and arranged to provide a magnetic field effective within the operating region to navigate the magnetic medical device within the operating region.

11. The system according to claim 10 wherein the magnets are capable of providing a magnetic field of at least about 0.1 Tesla anywhere in an operating region of at least about two inches by about two inches by about two inches.

12. The system according to claim 11 wherein the magnets are capable of providing a magnetic field of at least about 0.1 Tesla anywhere in an operating region of at least about five inches by about five inches by about five inches.

13. The system according to claim 10 wherein the magnets are capable of providing a magnetic field of at least about 0.3 Tesla anywhere in an operating region of at least about two inches by about two inches by about two inches.

14. The system according to claim 13 wherein the magnets are capable of providing a magnetic field of at least about 0.3 Tesla anywhere in an operating region of at least about five inches by about five inches by about five inches.

15. The system according to claim 10 wherein the center of the operating region is spaced at least about twelve inches from each magnet.

16. The system according to claim 10 wherein the magnets are electromagnetic coils.

17. The system according to claim 16 wherein the electromagnet coils are superconducting electromagnetic coils.

18. The system according to claim 16 wherein the operating region has a volume of at least about five inches by about five inches by about five inches.

19. The system according to claim 16 wherein the coils are sized and arranged so that the axes of any two coils lie in the same plane.

20. The system according to claim 16 wherein the coils are mutually perpendicular.

21. The system according to claim 16 wherein the axes of the coils intersect.

22. The system according to claim 16 wherein the axes of the coils intersect in the operating region.

23. The system according to claim 16 wherein the intersection of the axes of the magnets is at least about six inches from each of the coils, but no more than about fifteen inches from each of the coils.

24. The system according to claim 16 wherein the center of the operating region is at least six inches from each of the coils, but no more than about fifteen inches from each of the coils.

25. The system according to claim 16 wherein the coils are arranged and configured so that their axes intersect, and wherein the coils are spaced sufficiently from the point of intersection to accommodate a sphere centered on the point of intersection, with a radius of at least twelve inches.

26. The system according to claim 16 wherein the coils are arranged in a generally hemispherically shaped shell.

27. The system according to claim 26 wherein the generally hemispherically shaped shell is mounted so that the axis is at an angle with respect to vertical.

28. The system according to claim 27 wherein the generally hemispherically shaped shell is mounted for rotation about a vertical axis.

29. The system according to claim 26 wherein there is an opening in the shell, aligned with the center of one of the coils through which a portion of the patient'"'"'s body can extend.

30. The system according to claim 26 wherein the generally hemispherically shaped shell has an inner diameter greater than about twenty-five inches and an outer diameter less than about fifty inches.

31. The system according to claim 16 further comprising an imaging system comprising at least one imaging plate and an x-ray imaging source, the imaging system being movably mounted independently of the coils so that the imaging plate can be moved to positions between the patient and the coils.

32. The system according to claim 31 wherein the imaging system comprises at least two imaging plates and two x-ray imaging sources, and wherein each imaging plate and its respective x-ray source is movably mounted independently of the coils so that the imaging plates can be moved to positions between the patent and the coils.

33. The system according to claim 32 wherein each imaging plate and its respective x-ray source is fixedly mounted with respect to the other.

34. The system according to claim 32 wherein the lines between each imaging plate and its respective x-ray source are perpendicular.

35. The system according to claim 10 wherein said system comprises only three magnets and each of said magnets further comprises a superconducting magnet coil, said coils being generally arranged along the axes of an orthogonal coordinate system.

36. The system according to claim 35 wherein the origin of said orthogonal coordinate system is controlled to be within the operating region.

37. The system according to claim 36 wherein said coils are mounted to a generally hemispherically shaped shall, and wherein each coil has its central axis aligned along an axis of said orthogonal coordinate system.

38. The system according to claim 37 further comprising a support for the patient, and a moveable support for the shell so that said shell may be reoriented about said patient support and patient.

39. The system according to claim 38 wherein one of said coils has its central axis generally aligned with a central axis of the patient.

40. The system according to claim 39 wherein said operating region comprises a sphere shaped space having a radius of approximately two and one half inches and centered at approximately the coordinate system origin.

41. The system according to claim 40 wherein the shell and the coils are positioned to lie outside the operating region.

42. The system according to claim 41 further comprising a transport mechanism connecting the moveable shell support to the patent support for moving the shell about the patient support.

43. The system according to claim 42 wherein said coils are positioned so that their respective near field lines are substantially straight within the operating region.

44. The system according to claim 43 wherein each of said coils are sized to provide a field strength of at least about 0.3 Tesla.

45. The imaging system of claim 10 wherein the electromagnetic coils are configured to provide a magnetic field adjustable up to at least about 0.3 Tesla anywhere in the operating region.

46. A system for navigating a magnetic medical device within a patient, the system comprising a medical imaging device configured to provide an image of an operating region of a patient including the medical device therein;

and

a total of three navigating magnets configured and arranged to provide a magnetic field effective within the operating region to orient the magnetic medical device with in the operating region.

47. The system according to claim 46 wherein the magnets are electromagnetic coils.

48. The system according to claim 47 wherein the electromagnet coils are superconducting electromagnetic coils.

49. The system according to claim 47 wherein the imaging device comprises at least one imaging plate and associated x-ray source, and a support for mounting imaging plate and x-ray source for movement independent of the coils, the support permitting the imaging plate to be moved to positions between the patient and the coils.

50. The system according to claim 49 wherein the imaging device comprises at least two imaging plates and associated x-ray sources, and a support for mounting the imaging plates and x-ray sources for movement independent of the coils, the support permitting the imaging plates to be moved to positions between the patient and the coils.

51. The system according to claim 50 wherein the support is movable about three generally perpendicular axes.

52. The system according to claim 51 wherein the axes of the three coils intersect and wherein the three generally perpendicular axes of movement of the support each extend through the point of intersection.

53. The system according to claim 51 wherein lines between each imaging plate and its respective x-ray source are perpendicular.

54. The system according to claim 53 wherein each imaging plate and its x-ray source are fixedly mounted on the support with respect to the other.

55. The system according to claim 52 wherein the axes of the three coils intersect;

wherein the three coils are mounted in a frame for movement about at least one axis extending through the point of intersection; and

wherein the imaging device comprises at least one imaging plate and an x-ray source on a support, the support being movable about at least one axis that extends through the point of intersection.

56. A system for navigating a magnetic medical device within an operating region within a patient, the system comprising:

three electromagnetic coils configured and arranged to be able to provide a magnetic field of at least about 0.1 Tesla within an operating region at least about five inches by about five inches by about five inches which operating region is spaced at least about twelve inches from each of the coils, to selectively orient the magnetic medical device anywhere within the operating region.

57. The system according to claim 56 wherein the three electromagnetic coils are capable of providing a magnetic field of at least about 0.3 Tesla anywhere within the operating region.

58. The system according to claim 56 wherein the axes of three electromagnetic coils are mutually perpendicular.

59. The system according to claim 58 wherein the axes of the three electromagnetic coils intersect.

60. The system according to claim 59 wherein the three coils are mounted in a shell having a generally hemispherical shape.

61. The system according to claim 60 wherein the hemispherical shell is oriented so that its axis is at an angle greater than 0°

and less than 90°

with respect to vertical.

62. The system according to claim 61 wherein the shell is rotatably mounted about a vertical axis.

63. The system according to claim 62 wherein the coils are arranged so that their axes intersect at a point, and wherein the vertical axis of rotation of the shell extends through the point of intersection of the axes.

64. The system according to claim 56, further comprising a medical imaging device including at least one amorphous silicon plate imaging detector.

65. The system according to claim 56 wherein the three electromagnetic coils are fixed relative to one another and moveable relative to the patient.

66. The system according to claim 56 further comprising a medical imaging device, wherein the medical imaging device comprises at least one imaging plate that can be interposed between one of the three electromagnetic coils and the operating region.

67. The system according to claim 66 wherein the medical imaging device comprises first and second x-ray sources and corresponding first and second image plates for providing images of the operating region in two planes.

68. The system according to claim 56 further comprising a medical imaging device for providing images of the operating region in two perpendicular planes.

69. The system according to claim 68 wherein the coils are mounted in a generally hemispherically shaped shell, and wherein the image plates can extend into the shell in position between the operating region and at least one of the electromagnetic coils.

70. The system according to claim 69 wherein the medical imaging device is movable relative to the operating zone, independently of the magnet coils.

71. A system for navigating a magnetic medical device within an operating region within which a patient may be placed, the system comprising:

a total of three super conducting magnets configured such that each of their central axes lies generally along an axis of an orthogonal coordinate system having its origin approximately centered within said operating region, said magnets being supported by a generally hemispherical shell and each magnet being of sufficient strength to provide a magnetic field in the direction of its respective central axis having a generally consistent strength of about 0.3 Tesla throughout substantially the entirety of said operating region, and a control for adjusting the strength of the magnetic field of each of said magnets to thereby controllably navigate the magnetic medical device within the patient as the patient lies with a part of the patient'"'"'s body within the operating region.

72. A system for navigating a magnetic medical device within an operating region within a patient, the system comprising:

a support for at least a portion of the patient;

a magnet hood including three electromagnetic coils arranged and configured so that the axes of the coils converge,

a magnet mount holding the magnet hood so that the convergence of the axes would be within the operating region of the patient supported on the support;

an x-ray imaging assembly for providing an image of the operating region of a patient supported on the patient support, the imaging assembly comprising at least one imaging plate and an x-ray imaging beam source mounted on an imaging support to be on opposite sides of the operating region, and a C-arm mechanism for selectively pivoting the support about three mutually perpendicular axes.

73. The system according to claim 72 wherein the C-arm mechanism pivots the imaging support about three mutually perpendicular axes that extend through the operating region.

74. The system according to claim 72 wherein the C-arm mechanism pivots the imaging support about three mutually perpendicular axes that extend through point where the axes of the three magnets converge.

75. The system according to claim 74 wherein axes of the magnets intersect, and wherein the magnet mount mounts the magnet hood to pivot about at least one axis that extends through the point where the axes of the three magnets intersect.

76. A system for navigating a magnetic medical device through the part of a patient within an operating region of the system while providing an open environment around the patient, the system comprising:

a support for the patient;

a magnet hood assembly including a magnet hood supported by a magnet hood mount, the magnet hood having three navigating electromagnets configured to provide a selected magnetic field in the operating region; and

an x-ray imaging assembly including a portion disposed between the magnet hood and the operating region to provide a medical image of the operating region.

77. The system of claim 76 wherein the three electromagnets are electromagnetic coils configured to have essentially mutually perpendicular axes that converge in the operating region.

78. The system of claim 76 wherein the imaging assembly comprises:

a imaging support;

a mechanism for moving the imaging support relative to the patient;

an imaging plate operatively supported by the imaging support;

an imaging tube producing an imaging beam directed towards the imaging plate through the operating region, the imaging tube also being operatively supported by the imaging support so that movement of the imaging tube and the imaging plate are coordinated upon movement of the support, the imaging beam remaining directed toward the imaging plate through the operating region in at least a plurality of different positions of the support; and

at least one of the imaging tube and the imaging plate is disposed between the magnet assembly and the operating region in said plurality of different positions of the support.

79. The system of claim 78 wherein the magnet hood is moveably attached to the magnet hood support base in a manner to allow repositioning about the operating region separately from movement of the imaging assembly to provide greater freedom in imaging the operating region of the patient.

80. The system of claim 78 wherein at least one of the imaging tube and the imaging plate is adjustably supported by the support so that a distance between the imaging tube and the imaging plate is adjustable.

81. The system of claim 78 wherein the imaging plates are amorphous silicon imaging plates to provide immunity of the imaging system to strong magnetic fields.

82. The system of claim 78 wherein the magnet hood is moveably attached to the magnet hood support base in a manner to allow repositioning about the operating region.

83. The system of claim 78 wherein the electromagnetic coils are configured to provide a magnetic field adjustable up to at least 0.3 Tesla in the operating region without flexure of the magnet hood in excess of 1 millimeter from the adjustable magnetic field, and in which the electromagnetic coils are superconducting and include an associated cryogenic system on or supported by the magnetic hood, or both, and wherein the magnet hood, including the associated cryogenic system and electromagnetic coils, weigh less than about 5000 pounds.

84. The system of claim 78 wherein the three electromagnetic coils are confined within a magnet support hood having a generally hemispherical shape.

85. The system of claim 84 wherein the medical imaging device comprises movable imaging plates and movable imaging tubes having imaging beams directed towards the imaging plates through an operating region of a patient, and the magnet support hood has an axis of symmetry tilted to increase access of the imaging beams to the operating region of the patient.

86. The system of claim 85 wherein the magnet hood is rotatable about an axis.

87. A method of navigating a magnetic medical device within an operating region in a patient, the method comprising:

applying a magnetic field to the magnetic medical device in the operating zone with at least three electromagnetic coils contained within a magnet shell to navigate the medical device within the operating region; and

providing an image of the magnetic medical device in the operating region with an imaging apparatus comprising at least one imaging plate and an x-ray imaging beam source, the imaging plate and the x-ray imaging beam source being on opposite sides of the operating region, with the imaging plate being positioned between the operating region and the magnet shell.

88. A method of navigating a magnetic medical device within an operating region in a patient, the method comprising:

applying a magnetic field to the magnetic medical device in the operating region with at least three electromagnetic coils contained within a magnet shell having a concave opening to navigate the medical device within the operating region, the axes of the coils intersecting at a point in the operating region, while providing a real-time image of the magnetic medical device in the operating region with an imaging apparatus comprising at least one imaging plate and an imaging beam source, the imaging plate and imaging beam source being on opposite sides of the operating region, with the imaging plate being positioned between the operating region and the magnet shell.

89. The method according to claim 88 wherein the imaging plate and imaging beam source are movable about three mutually perpendicular axes which extend through the operating zone.

90. The method according to claim 89 wherein the imaging plate and imaging beam source are movable about three mutually perpendicular axes which extend through the point of intersection of the axes of the magnet.