Method and system for mounting an MPS sensor on a catheter

• US 20040097804A1
• Filed: 04/07/2003
• Published: 05/20/2004
• Est. Priority Date: 11/18/2002
• Status: Active Grant

• Current Assignee: ST JUDE MEDICAL INTERNATIONAL HOLDING S. R.L.
• Original Assignee: MediGuide Ltd (Abbott Laboratories Incorporated)
• Inventors: Sobe, Lior
• Granted Patent: US 7,881,769 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Catheter for performing a medical operation on an organic lumen, the catheter including an elongated member, a medical operational element located at a distal end of the elongated member, an electromagnetic field detector located at the distal end, and a wiring for coupling the electromagnetic field detector with a medical positioning system, wherein the medical positioning system determines the position and orientation of the distal end.

Claims

1. Catheter for performing a medical operation on an organic lumen, the catheter comprising:

an elongated member;

a medical operational element located at a distal end of said elongated member;

an electromagnetic field detector located at said distal end; and

a wiring for coupling said electromagnetic field detector with a medical positioning system,

wherein said medical positioning system determines the position and orientation of said distal end.

2. The catheter according to claim 1, wherein said electromagnetic field detector is embedded within said elongated member.

3. The catheter according to claim 1, wherein said elongated member includes a guidewire lumen for a guidewire to pass through said guidewire lumen.

4. The catheter according to claim 3, wherein said electromagnetic field detector is located at a side of said guidewire lumen.

5. The catheter according to claim 3, wherein said electromagnetic field detector is in form of a coil which surrounds at least a portion of said guidewire lumen.

6. The catheter according to claim 3, wherein a guidewire lumen distal end of said guidewire lumen is located at an elongated member distal end of said elongated member, and

wherein a guidewire lumen proximal end of said guidewire lumen is located at an elongated member proximal end of said elongated member.

7. The catheter according to claim 3, wherein a guidewire lumen distal end of said guidewire lumen is located at an elongated member distal end of said elongated member, and

wherein a guidewire lumen proximal end of said guidewire lumen is located at a side portion of said elongated member.

8. The catheter according to claim 7, wherein said electromagnetic field detector is wound around a material that exhibits magnetism, and

wherein said electromagnetic field detector is located proximal to said guidewire lumen proximal end.

9. The catheter according to claim 8, wherein said material is selected from the list consisting of:

ferromagnetic; and

paramagnetic;

10. The catheter according to claim 7, wherein said electromagnetic field detector is located proximal to said guidewire lumen proximal end.

11. The catheter according to claim 1, wherein said wiring modifies at least one mechanical property of said elongated member.

12. The catheter according to claim 11, wherein said at least one mechanical property is selected from the list consisting of:

pushability;

trackability;

elasticity;

flexibility;

modulus of elasticity; and

coefficient of rigidity.

13. The catheter according to claim 1, wherein said wiring is embedded within said elongated member.

14. The catheter according to claim 13, wherein said wiring is substantially straight along the length of said elongated member.

15. The catheter according to claim 13, wherein at least a portion of said wiring is wound in a spiral form having a pitch of at least one value, along the length of said elongated member, and

wherein at least another portion of said wiring is substantially straight along the length of said elongated member.

16. The catheter according to claim 13, wherein said wiring is wound in a spiral form.

17. The catheter according to claim 16, wherein said wiring is wound at a constant pitch along the length of said elongated member.

18. The catheter according to claim 16, wherein said wiring is wound in at a plurality of different pitches along the length of said elongated member.

19. The catheter according to claim 16, wherein said wiring is placed in a spiral groove on an outer wall of said elongated member.

20. The catheter according to claim 19, wherein said groove is made by employing a technique selected from the list consisting of:

laser;

mechanical engraving;

chemical etching;

molding;

injection; and

extrusion.

21. The catheter according to claim 1, wherein said wiring is coated with an electrically shielding coating.

22. The catheter according to claim 21, wherein said electrically shielding coating comprises a fluid.

23. The catheter according to claim 21, wherein said wiring is hollow, a hollow space thereof including a fluid.

24. The catheter according to claim 1, wherein said wiring comprises:

a first electrical conductor enclosed by a first electrical insulator;

a second electrical conductor enclosed by a second electrical insulator;

an electrical shielding enclosing said first electrical conductor and said second electrical conductor; and

an outer electrical insulator enclosing said electrical shielding,

wherein said first electrical conductor and said second electrical conductor are twisted there about.

25. The catheter according to claim 1, wherein said wiring comprises:

a first electrical conductor having a substantially annular cross section;

a second electrical conductor having a substantially round cross section, said second electrical conductor being concentrically located within said first electrical conductor;

an intermediate electrical insulator filling the space between said first electrical conductor and said second electrical conductor; and

an outer electrical insulator enclosing said first electrical conductor.

26. The catheter according to claim 1, wherein said wiring comprises:

an electrical shielding having a substantially annular cross section;

a first electrical conductor having a substantially annular cross section, said first electrical conductor being concentrically located within said electrical shielding;

a second electrical conductor having a substantially round cross section, said second electrical conductor being concentrically located within said first electrical conductor;

a first intermediate electrical insulator filling the space between said shielding and said first electrical conductor;

a second intermediate electrical insulator filling the space between said first electrical conductor and said second electrical conductor; and

an outer electrical insulator enclosing said electrical shielding.

27. The catheter according to claim 1, wherein the outer contour of said elongated member is substantially circular.

28. The catheter according to claim 1, wherein a first electrical conductor of said wiring is embedded within said elongated member along a first path,

wherein a second electrical conductor of said wiring is embedded within said elongated member along a second path,

wherein said first path and said second path substantially lie on a plane, said plane substantially passing through the longitudinal axis of said elongated member, and

wherein said first path and second path are substantially equally spaced from said longitudinal axis.

29. The catheter according to claim 1, wherein a first electrical conductor of said wiring, a second electrical conductor of said wiring, and a support element, are all embedded within said elongated member in substantially straight lines, and

wherein said first electrical conductor, said second electrical conductor and said support element substantially lie equally apart on a circle, said circle being substantially concentric with a longitudinal axis in a lateral cross section of said elongated member.

30. The catheter according to claim 1, further comprising a radiopaque marker embedded within said elongated member at said distal end, wherein an image of said radiopaque marker indicates the position of said distal end.

31. The catheter according to claim 1, wherein said electromagnetic field detector is made of a radiopaque material.

32. The catheter according to claim 1, wherein said medical operational element is selected from the list consisting of:

balloon;

stent;

balloon expanding stent;

laser;

cryogenic fluid unit;

electric impulse unit;

cutting balloon;

rotational atherectomy unit;

directional atherectomy unit;

transluminal extraction unit;

coated stent;

drug delivery balloon;

brachytherapy unit;

valve;

suturing device;

implant;

biological marker;

radiopaque marker;

substance delivery device;

imaging device;

diagnostic device;

miniature camera;

infrared camera;

optical coherence tomography;

magnetic resonance imaging;

ultrasound; and

sensor.

33. The catheter according to claim 32, wherein said stent is made of a shape memory alloy.

34. The catheter according to claim 32, wherein said stent is enclosed by a sleeve,

wherein said sleeve keeps said stent in a compressed state, and

wherein said stent expands when said sleeve is removed.

35. The catheter according to claim 1, wherein said wiring is deployed only along a distal portion of said elongated member, said catheter further comprises a transmitter, said transmitter is coupled to a proximal end of said wiring;

and

wherein said transmitter wirelessly couples said electromagnetic field detector with said medical positioning system.

36. The catheter according to claim 1, further comprising a shielding covering at least a portion of said electromagnetic field detector, wherein said shielding is of such physical dimensions and properties, that said shielding shields said electromagnetic field detector against at least one electromagnetic field source.

37. The catheter according to claim 1, wherein a circumferential fluid lumen encompasses at least a portion of said elongated member, said circumferential fluid lumen containing a fluid, said fluid providing electromagnetic shielding for said wiring in predetermined ranges of frequencies.

38. Position and orientation determination system comprising:

a guiding catheter; and

a guiding catheter electromagnetic field detector located at a guiding catheter distal end of said guiding catheter, said guiding catheter electromagnetic field detector being coupled with a medical positioning system,

wherein said medical positioning system determines the position and orientation of said guiding catheter distal end, relative to a reference coordinate system.

39. The system according to claim 38, wherein said guiding catheter electromagnetic field detector is wound around an outer wall of said guiding catheter.

40. The system according to claim 38, wherein said guiding catheter electromagnetic field detector is located within a wall of said guiding catheter.

41. The system according to claim 38, further comprising at least one medical catheter located within said guiding catheter, said at least one medical catheter comprising:

an elongated member;

a medical operational element located at at least one medical catheter distal end of a respective one of said at least one medical catheter;

a medical catheter electromagnetic field detector located at said at least one medical catheter distal end, and

a wiring for coupling said medical catheter electromagnetic field detector with said medical positioning system,

wherein said medical positioning system determines the position and orientation of said at least one medical catheter distal end, relative to a reference coordinate system.

42. The system according to claim 41, wherein said elongated member includes a guidewire lumen for a guidewire to pass through said guidewire lumen.

43. The system according to claim 38, further comprising at least one medical catheter located within said guiding catheter, said at least one medical catheter comprising:

an elongated member;

a medical operational element located at at least one medical catheter distal end of a respective one of said at least one medical catheter;

a medical catheter electromagnetic field detector located at said at least one medical catheter distal end; and

a wiring for coupling said medical catheter electromagnetic field detector with said medical positioning system,

wherein said medical positioning system determines the position and orientation of said at least one medical catheter distal end, relative to said guiding catheter distal end.

44. The system according to claim 38, further comprising at least one medical catheter located within said guiding catheter, said at least one medical catheter comprising:

an elongated member;

a medical operational element located at at least one medical catheter distal end of a respective one of said at least one medical catheter;

a medical catheter electromagnetic field detector located at said at least one medical catheter distal end; and

a wiring for coupling said medical catheter electromagnetic field detector with said medical positioning system,

wherein said medical positioning system determines the position and orientation of at least one of said at least one medical catheter distal end, relative to at least another one of said at least one medical catheter distal end.

45. Method for performing a medical operation on an organic lumen, the method comprising the procedures of:

advancing a medical catheter to a desired location within said organic lumen;

coupling an electromagnetic field detector located at a medical catheter distal end of said medical catheter, with a medical positioning system, by a wiring;

generating an electromagnetic field by said medical positioning system;

detecting said generated electromagnetic field by said electromagnetic field detector;

transmitting a signal respective of said detected electromagnetic field, to said medical positioning system, via said wiring;

determining the position and orientation of said medical catheter distal end, by said medical positioning system, according to said transmitted signal; and

performing said medical operation, by activating a medical operational element located at said medical catheter distal end.

46. The method according to claim 45, further comprising a preliminary procedure of advancing a guiding catheter to said desired location.

47. The method according to claim 45, further comprising a preliminary procedure of advancing a guidewire within a guiding catheter to said desired location, before said procedure of advancing said medical catheter.

48. The method according to claim 47, wherein said procedure of advancing said medical catheter to said desired location, comprises a sub-procedure of advancing said medical catheter within said guiding catheter, by inserting a proximal guidewire end of said guidewire through said medical catheter distal end, and withdrawing said proximal guidewire end out of an exit port of said medical catheter.

49. The method according to claim 48, wherein said exit port is located at a medical catheter proximal end of said medical catheter.

50. The method according to claim 48, wherein said exit port is located at a side of said medical catheter, proximal to said medical operational element.

51. The method according to claim 48, further comprising a preliminary procedure of advancing said guidewire within said guiding catheter to said desired location, past a guiding catheter distal end of said guiding catheter.

52. The method according to claim 51, further comprising a preliminary procedure of advancing said guiding catheter to an approximate location proximal to said desired location within said organic lumen.

53. The method according to claim 45, further comprising a preliminary procedure of forming said electromagnetic field detector into a coil, wherein said coil surrounds at least a portion of an elongated member of said medical catheter.

54. The method according to claim 53, further comprising a preliminary procedure of covering at least a portion of said electromagnetic field detector with a shielding.

55. The method according to claim 54, wherein said shielding is of such physical dimensions and properties, that said shielding shields said electromagnetic field detector against at least one electromagnetic field source.

56. The method according to claim 53, further comprising a preliminary procedure of applying a coating to said electromagnetic field detector, wherein said coating is made of a material which provides mechanical protection to said electromagnetic field detector.

57. The method according to claim 53, further comprising a preliminary procedure of applying a coating to said electromagnetic field detector, wherein said coating is made of a radiopaque material.

58. The method according to claim 45, further comprising a preliminary procedure of forming said electromagnetic field detector by winding an electrical conductor to a coil.

59. The method according to claim 58, wherein said coil surrounds at least a portion of a guidewire lumen of said elongated member, for a guidewire to pass through said guidewire lumen

60. The method according to claim 45, wherein said electromagnetic field detector is located to a side of a guidewire lumen of said elongated member, for a guidewire to pass through said guidewire lumen.

61. The method according to claim 45, further comprising a preliminary procedure of forming said electromagnetic field detector by winding an electrical conductor around a material whose permeability is substantially greater than that of the air.

62. The method according to claim 45, further comprising a procedure of applying a coating to said wiring, before said procedure of coupling, wherein said coating is made of a material which electrically insulates said wiring.

63. The method according to claim 45, further comprising a preliminary procedure of applying a coating to said wiring, wherein said coating is made of a material which provides mechanical protection to said wiring.

64. The method according to claim 45, further comprising a procedure of applying a coating to said wiring, before said procedure of coupling, wherein said coating provides electrical shielding.

65. The method according to claim 45, wherein said procedure of coupling comprises a sub-procedure of disposing said wiring along an elongated member of said medical catheter, in form of a spiral.

66. The method according to claim 65, wherein the pitch of said spiral is substantially constant.

67. The method according to claim 65, wherein said spiral has at least two pitches.

68. The method according to claim 45, wherein said procedure of coupling comprises a sub-procedure of disposing said wiring along an elongated member of said medical catheter, in a substantially straight form.

69. The method according to claim 45, wherein said procedure of coupling comprises a sub-procedure of disposing said wiring along an elongated member of said medical catheter, in a partially substantially spiral form and a partially substantially straight form.

70. The method according to claim 45, further comprising a preliminary procedure of embedding said wiring within an elongated member of said medical catheter.

71. The method according to claim 45, further comprising a preliminary procedure of disposing said wiring on an outer wall of an elongated member of said medical catheter.

72. The method according to claim 45, further comprising a preliminary procedure of forming a groove on an outer wall of an elongated member of said medical catheter, for said wiring.

73. The method according to claim 45, further comprising preliminary procedures of:

coating a first electrical conductor of said wiring with a first electrical insulator;

coating a second electrical conductor of said wiring with a second electrical insulator;

twisting said first coated electrical conductor with said second coated electrical conductor, thereby forming a twisted pair;

coating said coated twisted pair with an electrical shielding; and

coating said electrical shielding with an outer electrical insulator.

74. The method according to claim 45, further comprising preliminary procedures of:

passing a first electrical conductor of said wiring within a second electrical conductor of said wiring, said first electrical conductor having a substantially round cross section, said second electrical conductor having a substantially annular cross section,

filling the space between said first electrical conductor and said second electrical conductor, with an intermediate electrical insulator, and

coating said second electrical conductor with an outer electrical insulator.

75. The method according to claim 45, further comprising preliminary procedures of:

passing a first electrical conductor of said wiring within a shielding, each of said first electrical conductor and said shielding having a substantially annular cross section, a first diameter of said first electrical conductor being smaller than a second diameter of said shielding;

passing a second electrical conductor within said first electrical conductor, said second electrical conductor having a substantially round cross section;

filling the space between said first electrical conductor and said shielding, with a first intermediate electrical insulator;

filling the space between said first electrical conductor and said second electrical conductor, with a second intermediate electrical insulator; and

coating said shielding with an outer electrical insulator.

76. The method according to claim 45, further comprising preliminary procedures of:

embedding a first electrical conductor of said wiring along a first path within an elongated member of said medical catheter; and

embedding a second electrical conductor of said wiring along a second path within said elongated member,

wherein said first path and said second path are located on a plane, said plane passing through the longitudinal axis of said elongated member.

77. The method according to claim 45, further comprising a preliminary procedure of embedding a first electrical conductor of said wiring, a second electrical conductor of said wiring, and a support element, within said elongated member in substantially straight lines, wherein said first electrical conductor, said second electrical conductor and said support element substantially lie equally apart on a circle, said circle being substantially concentric with a longitudinal axis in a lateral cross section of said elongated member.

78. The method according to claim 45, further comprising a preliminary procedure of embedding a radiopaque marker within an elongated member of said medical catheter.

79. The method according to claim 45, wherein said medical operation is selected from the list consisting of:

percutaneous transluminal coronary angioplasty;

percutaneous transluminal angioplasty;

vascularizing an organic lumen;

severing a portion of said lumen;

severing a plaque within said lumen;

providing a suture to said lumen;

increasing the inner diameter of said lumen;

maintaining said increased inner diameter by implanting a stent within said lumen;

delivering a pharmaceutical substance to a selected site within said lumen;

deploying devices within said lumen;

killing selected cells at an activation site of said medical operational element;

killing selected cells in the vicinity of said activation site; and

valvuloplasty.

80. Position and orientation determination method, the method comprising the procedures of:

coupling an electromagnetic field detector located at a guiding catheter distal end of a guiding catheter, with a medical positioning system;

generating an electromagnetic field by said medical positioning system;

detecting said generated electromagnetic field, by said electromagnetic field detector;

transmitting a signal respective of said detected electromagnetic field, by said electromagnetic field detector; and

determining the position and orientation of said guiding catheter distal end relative to a reference coordinate system, by said medical positioning system, according to said transmitted signal.

81. The method according to claim 80, further comprising a preliminary procedure of advancing said guiding catheter within an organic lumen, to an approximate location proximal to a desired location within said organic lumen.

82. The method according to claim 80, further comprising the procedures of:

advancing at least one medical catheter to at least one respective desired location within an organic lumen;

coupling at least one electromagnetic field detector located at at least one respective medical catheter distal end of said at least one medical catheter, with a medical positioning system;

generating an electromagnetic field by said medical positioning system;

detecting said generated electromagnetic field by said at least one electromagnetic field detector;

transmitting at least one signal respective of said detected electromagnetic field, to said medical positioning system; and

determining the position and orientation of said at least one respective medical catheter distal end relative to said reference coordinate system, by said medical positioning system, according to a respective one of said at least one transmitted signal.

83. The method according to claim 82, wherein said at least one medical catheter is advanced to said at least one respective desired location, over at least one respective guidewire.

84. The method according to claim 83, wherein said procedure of advancing said at least one medical catheter to said at least one respective desired location, comprises a sub-procedure of advancing said at least one medical catheter within said guiding catheter, by inserting a proximal guidewire end of said at least one respective guidewire through said at least one respective medical catheter distal end, and withdrawing said proximal guidewire end, out through a respective at least one medical catheter proximal end of said at least one medical catheter.

85. The method according to claim 84, further comprising a preliminary procedure of advancing said at least one respective guidewire within said guiding catheter to said at least one respective desired location, past a guiding catheter distal end of said guiding catheter.

86. The method according to claim 83, wherein said procedure of advancing said at least one medical catheter to said at least one respective desired location, comprises a sub-procedure of advancing said at least one medical catheter within said guiding catheter, by inserting a proximal guidewire end of said at least one respective guidewire through said at least one respective medical catheter distal end, and withdrawing said proximal guidewire end, out through a respective side port of said at least one medical catheter, said respective side port being located proximal to a respective medical operational element, said respective medical operational element being located at said at least one respective medical catheter distal end.

87. The method according to claim 80, further comprising the procedures of:

advancing at least one medical catheter to at least one respective desired location within an organic lumen;

coupling at least one electromagnetic field detector located at at least one respective medical catheter distal end of said at least one medical catheter, with a medical positioning system;

generating an electromagnetic field by said medical positioning system;

detecting said generated electromagnetic field by said at least one electromagnetic field detector;

transmitting at least one signal respective of said detected electromagnetic field, to said medical positioning system; and

determining the position and orientation of said at least one respective medical catheter distal end relative to said guiding catheter distal end, by said medical positioning system, according to a respective one of said at least one transmitted signal.

88. The method according to claim 87, wherein said at least one medical catheter is advanced to said at least one respective desired location, over at least one respective guidewire.

89. The method according to claim 80, further comprising the procedures of:

advancing at least one medical catheter to at least one respective desired location within an organic lumen;

coupling at least one electromagnetic field detector located at at least one respective medical catheter distal end of said at least one medical catheter, with a medical positioning system;

generating an electromagnetic field by said medical positioning system;

detecting said generated electromagnetic field by said at least one electromagnetic field detector;

transmitting at least one signal respective of said detected electromagnetic field, to said medical positioning system; and

determining the position and orientation of said at least one medical catheter distal end, relative to at least another one of said at least one medical catheter distal end, by said medical positioning system, according to a respective one of said at least one transmitted signal.

90. The method according to claim 89, wherein said at least one medical catheter is advanced to said at least one respective desired location, over at least one respective guidewire.