CA2493869A1 - Apparatus for catheter guidance control and imaging - Google Patents

Apparatus for catheter guidance control and imaging Download PDF

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Publication number
CA2493869A1
CA2493869A1 CA002493869A CA2493869A CA2493869A1 CA 2493869 A1 CA2493869 A1 CA 2493869A1 CA 002493869 A CA002493869 A CA 002493869A CA 2493869 A CA2493869 A CA 2493869A CA 2493869 A1 CA2493869 A1 CA 2493869A1
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Prior art keywords
distal end
magnetic field
magnetic
virtual tip
cluster
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Granted
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CA002493869A
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French (fr)
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CA2493869C (en
Inventor
Yehoshua Shachar
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Magnetecs Inc
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Magnetecs, Inc.
Yehoshua Shachar
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Publication of CA2493869A1 publication Critical patent/CA2493869A1/en
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Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/73—Manipulators for magnetic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/76—Manipulators having means for providing feel, e.g. force or tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7455—Details of notification to user or communication with user or patient ; user input means characterised by tactile indication, e.g. vibration or electrical stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00694—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body
    • A61B2017/00703—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body correcting for movement of heart, e.g. ECG-triggered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/102—Modelling of surgical devices, implants or prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/73—Manipulators for magnetic surgery
    • A61B2034/731—Arrangement of the coils or magnets
    • A61B2034/732—Arrangement of the coils or magnets arranged around the patient, e.g. in a gantry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/74—Manipulators with manual electric input means
    • A61B2034/742—Joysticks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0158—Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

A system whereby a magnetic tip attached to a surgical tool is detected, displayed and influenced positionally so as to allow diagnostic and therapeutic procedures to be performed rapidly, accurately, simply, and intuitively is described. The tools that can be so equipped include catheter s, guidewires, and secondary tools such as lasers and balloons, in addition biopsy needles, endoscopy probes, and similar devices. The magnetic tip allo ws the position and orientation of the tip to be determined without the use of x- rays by analyzing a magnetic field. The magnetic tip further allows the tool tip to be pulled, pushed, turned, and forcefully held in the desired positio n by applying an appropriate magnetic field external to the patient's body. A Virtual Tip serves as an operator control. Movement of the operator control produces corresponding movement of the magnetic tip inside the patient's bod y. Additionally, the control provides tactile feedback to the operator's hand i n the appropriate axis or axes if the magnetic tip encounters an obstacle. The output of the control combined with the magnetic tip position and orientatio n feedback allows a servo system to control the external magnetic field by pul se width modulating the positioning electromagnet. Data concerning the dynamic position of amoving body part such as a beating heart offsets the servo systems response in such a way that the magnetic tip, and hence the secondar y tool is caused to move in unison with the moving body part. The tip position and orientation information and the dynamic body part position information a re also utilized to provide a display that allows three dimensional viewing of the magnetic tip position and orientation relative to the body part.

Claims (66)

1. An apparatus for controlling the movement of a catheter-like tool to be inserted into the body of a patient, comprising;
a magnetic field source for generating a magnetic field outside the body;
a tool having a distal end responsive to said magnetic field;
one or more magnetic sensors to sense a magnetic field produced by said distal end;
and a system controller for controlling said magnetic field source to provide a position and command input to control said tool distal end position.
2. The apparatus of Claim 1, said system controller comprising a closed-loop feedback servo system.
3. The apparatus of Claim 1, said distal end comprising one or more magnetic field sensors and one or more temperature sensors.
4. The apparatus of Claim 1, said distal end comprising one or more magnetic field sensors for providing sensor data to said system controller.
5. The apparatus of Claim 1, further comprising an operator interface unit.
6. The apparatus of Claim 1, wherein said servo system comprises a correction input that compensates for a dynamic position of an organ, thereby offsetting a response of said distal end to said magnetic field such that said distal end moves in substantial unison with said organ.
7. The apparatus of Claim 6, wherein said correction input is generated by an auxiliary device that provides correction data concerning said dynamic position of said organ, and wherein when said correction data are combined with measurement data derived from said sensory apparatus to offset a response of said servo system so that said distal end moves substantially in unison with said organ.
8. The apparatus of Claim 7, wherein said auxiliary device is at least one of an x-ray device, an ultrasound device, and a radar device.
9. The apparatus of Claim 1, wherein said system controller includes a Virtual Tip control device to allow user control inputs.
10. The apparatus of Claim 1, further comprising:
a Virtual Tip and Calibration Fixture Controller; and a Virtual Tip assembly.
11. The apparatus of Claim 1, further comprising:
an X-Axis controller and amplifier;
a Y-Axis controller and amplifier; and a Z-Axis controller and amplifier.
12. The apparatus of Claim 1, further comprising:
a communication controller;
a calibration fixture; and one or more temperature sensors.
13. The apparatus of Claim 12, wherein said temperature sensors are paired with said magnetic field sensors.
14. The apparatus of Claim 1, wherein said system controller coordinates operation of an X-Axis Controller, a Y-Axis Controller, and a Z-Axis Controller, and wherein said system controller according to inputs from a Virtual Tip.
15. The apparatus of Claim 14, wherein said Virtual Tip provides tactile feedback to an operator.
16. The apparatus of Claim 14, wherein said Virtual Tip provides tactile feedback to an operator according to a position error between an actual position of said distal end and a desired position of said distal end.
17. The apparatus of Claim 14, wherein said system controller causes said distal end to follow movements of said Virtual Tip.
18. The apparatus of Claim 14, further comprising a Virtual Tip/Calibration Fixture Controller that receives encoder position, limit switch, and operator switch data from said Virtual Tip; and wherein said Virtual Tip/Calibration Fixture Controller outputs a tactile feedback response control to said Virtual Tip.
19. The apparatus of Claim 1, wherein said system controller is configured to calculate a position error of said distal end using at least in part data from said magnetic field sensor and to control said magnetic field source to correct said position error.
20. The apparatus of Claim 1, wherein said system controller initiates a tactile feedback response by providing feedback data to an operator control.
21. A method for controlling movement of a tool having a distal end to be inserted in a body, comprising;
applying a force to said distal end by generating an external magnetic field;
regulating said force to move said distal end in a desired direction; and locating said distal end by measuring a magnetic field of said distal end.
22. The method of Claim 21, further comprising changing a visual representation of said distal end in substantially real time as said distal end moves through the body.
23. The method of Claim 21, further comprising controlling one or more electromagnets to produce said external magnetic field..
24. The method of Claim 21, further comprising measuring a temperature of one or more magnetic field sensors that measure said magnetic field of said distal end.
25. The method of Claim 21, further comprising determining a current position of said distal end in comparison to a desired location.
26. The method of Claim 25, wherein determining said current position of said tool distal end comprises:
inhibiting modulator outputs of a system controller;
inputting a dynamic cardio position via a communication controller; and calculating said current position as a function of said cardio position.
27. The method of Claim 21, further comprising computing a position error of said distal end.
28. The method of Claim 27, further comprising altering at least one of a duty cycle and a polarity of modulation inputs to at least one of said X-axis controller, said Y-axis controller, and said Z-axis controller when said position error is greater than a specified minimum value.
29. The method of Claim 27, further comprising producing a tactile feedback if said position error exceeds a predetermined amount along at least one axis.
30. The method of Claim 21, wherein said system controller causes said tool distal end to move so that its position corresponds to position data from a Virtual Tip.
31. An apparatus for controlling movement of a tool having a distal end to be inserted in a body, comprising;
a magnet source configured in a cluster-like arrangement on a C-Arm forming said closed magnetic circuit and generating a magnetic field;
a tool having a distal end responsive to said magnetic field;
one or more piezoelectric rings disposed about said distal end; and a system controller for regulating said magnetic field to provide a position and command input to control said tool distal end position.
32. The apparatus of Claim 31, further comprising a closed servo loop system that receives said position and command input from said system controller, to regulate said magnetic force.
33. The apparatus of Claim 32, said distal end comprising one or more magnetic field sensors and one or more temperature sensors.
34. The apparatus of Claim 33, said control system configured to calculate respective torque and associated current for in said magnetic source to configure said magnetic field to move said distal end to a desired location.
35. The apparatus of Claim 34, wherein said closed servo loop circuit includes a correction input that compensates for dynamic position of patient's organs comprising orientation of said tool thereby offsetting said response of said distal end to said magnetic field such that said distal end moves in substantial unison with said organ.
36. The apparatus of Claim 35, wherein said correction input is generated by an auxiliary device that provides data concerning said dynamic position of said organ, and wherein when said data are combined with a set of fiduciary markers forming said stereotactic framing, said position definition measurement data derived from said sensory apparatus, serves to offset a response of said servo system, so that said distal end moves in unison with said organ.
37. The apparatus of Claim 36, wherein said auxiliary device is any one or more of: x-ray, ultrasound, or radar equipment forming said stereotactic frame of reference incorporating position data relative to frame of reference dynamically moving in unison with said body organs such as cardio output, electrocardiogram and pulmonary expansion and contraction.
38. The apparatus of Claim 31, wherein said system controller includes a Virtual Tip, wherein movement of at least a portion of said Virtual Tip causes the system controller to control electromagnets to move said distal end correspondingly.
39. An apparatus for controlling the movement of a catheter-like tool to be inserted into the body of a patient, comprising;
a controllable magnetic field source having a first cluster of poles and a second cluster of poles, said first cluster of poles substantially opposed to said second cluster of poles;
a tool having a distal end responsive to said magnetic field; and one or more magnetic sensors to sense a magnetic field produced by said distal end.
40. The apparatus of Claim 39, said distal end comprising one or more magnetic field sensors and one or more temperature sensors.
41. The apparatus of Claim 39, said distal end comprising one or more magnetic field sensors for providing sensor data to a system controller.
42. The apparatus of Claim 39, further comprising an operator interface unit.
43. The apparatus of Claim 39, wherein said first cluster of poles is connected to said second cluster of poles by a magnetic material.
44. The apparatus of Claim 39, further comprising a Virtual Tip control device to allow user control inputs.
45. The apparatus of Claim 39, further comprising:
a Virtual Tip and Calibration Fixture Controller; and a Virtual Tip assembly.
46. The apparatus of Claim 39, further comprising:
a communication controller;
a calibration fixture; and one or more temperature sensors.
47. The apparatus of Claim 39, wherein said temperature sensors are paired with said magnetic field sensors.
48. The apparatus of Claim 39, further comprising a Virtual Tip that provides tactile feedback to an operator.
49. The apparatus of Claim 48, wherein said Virtual Tip provides tactile feedback to an operator according to a position error between an actual position of said distal end and a desired position of said distal end.
50. The apparatus of Claim 39, further comprising a system controller to control a magnetic field produced by said three-dimensional magnetic field source to cause said distal end to follow movements of a Virtual Tip.
51. An apparatus for generating a magnetic field, comprising;
a first cluster of first electromagnet poles provided to a mass of magnetic material;
a first plurality of electromagnet coils provided to said first electromagnet poles, said first plurality of electromagnet coils controllable on a substantially separate basis;
a second cluster of second electromagnet poles provided to said mass of magnetic material such that said second cluster of second electromagnet poles substantially opposes said first cluster of first electromagnet poles, said magnetic mass completing a magnetic circuit from said first cluster said second cluster; and a second plurality of electromagnet coils provided to said second electromagnet poles, said second plurality of electromagnet coils controllable on a substantially separate basis such that an orientation of a magnetic field in a region between said first cluster and said second cluster is controllable in multiple dimensions.
52. The apparatus of Claim 51, wherein said first cluster of first electromagnet poles comprises three electromagnet poles.
53. The apparatus of Claim 51, wherein pole faces of said first electromagnet poles lie substantially on a sphere.
54. The apparatus of Claim 51, wherein pole faces of said first electromagnet poles lie substantially on a sphere and where pole faces of said second electromagnet poles lie substantially on said sphere.
55. The apparatus of Claim 51, further comprising a system controller to control electric currents in said first plurality of coils and said second plurality of coils to control said orientation of said magnetic field.
56. The apparatus of Claim 51, further comprising:
a tool having a distal end responsive to said orientation of said magnetic field; and one or more magnetic sensors to sense a magnetic field produced by said distal end.
57. The apparatus of Claim 56, said distal end comprising one or more magnetic field sensors and one or more temperature sensors.
58. The apparatus of Claim 56, further comprising a Virtual Tip control device to allow user control inputs.
59. The apparatus of Claim 56, further comprising a Virtual Tip that provides tactile feedback to an operator.
60. The apparatus of Claim 59, wherein said Virtual Tip provides tactile feedback to an operator according to a position error between an actual position of said distal end and a desired position of said distal end.
61. The apparatus of Claim 56, further comprising a system controller to control electric currents in said first plurality of coils and said second plurality of coils to control said orientation of said magnetic field to apply magnetic force to said distal end.
62 A catheter tip assembly, comprising;
a permanent magnet; and one or more piezoelectric rings.
63. A method for controlling movement of a tool having a distal end to be inserted in a body, comprising;
calculating a desired direction of movement for said distal end;
computing a magnetic field needed to produce said movement;
controlling a plurality of electric currents to produce said magnetic field;
and locating said distal end by measuring a magnetic field of said distal end.
64. The method of Claim 21, wherein said computing a magnetic field comprises:
determining a current position of said distal end with respect to one or more magnet poles; and using a lookup table to find said magnetic field needed to produce said movement.
65. The method of Claim 63, further comprising controlling one or more electromagnets to produce said external magnetic field..
66. The method of Claim 63, further comprising measuring a temperature of one or more magnetic field sensors that measure said magnetic field of said distal end.
CA2493869A 2002-07-16 2003-07-16 Apparatus for catheter guidance control and imaging Expired - Fee Related CA2493869C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39630202P 2002-07-16 2002-07-16
US60/396,302 2002-07-16
PCT/US2003/022122 WO2004006795A1 (en) 2002-07-16 2003-07-16 Apparatus for catheter guidance control and imaging

Publications (2)

Publication Number Publication Date
CA2493869A1 true CA2493869A1 (en) 2004-01-22
CA2493869C CA2493869C (en) 2012-11-20

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US (4) US7769427B2 (en)
EP (2) EP2105154A3 (en)
JP (2) JP4511351B2 (en)
CN (2) CN100438826C (en)
AT (1) ATE440560T1 (en)
AU (1) AU2003249273A1 (en)
CA (1) CA2493869C (en)
DE (1) DE60328990D1 (en)
WO (1) WO2004006795A1 (en)

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US7769427B2 (en) 2010-08-03
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US20060116633A1 (en) 2006-06-01
US20040019447A1 (en) 2004-01-29
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US20060114088A1 (en) 2006-06-01
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US7873401B2 (en) 2011-01-18
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US20060116634A1 (en) 2006-06-01
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JP2005532878A (en) 2005-11-04

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