Apparatus and method for catheter guidance control and imaging

• US 7,769,427 B2
• Filed: 07/15/2003
• Issued: 08/03/2010
• Est. Priority Date: 07/16/2002
• Status: Expired due to Fees

• Current Assignee: Neuro-Kinesis Corporation
• Original Assignee: Magnetics Inc.
• Inventors: Shachar, Yehoshua
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US10/621,196
• Publication Number:
  US 20040019447A1
• Time in Patent Office: 2,576 Days
• Field of Search: 600433-435, 600/585, 600/424, 604 9501- 9505, 604/528, 604/529, 606/108
• US Class Current: 600/424
• CPC Class Codes: A61B 17/22 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 dilators A61M29/00
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2034/732 arranged around the patient, e.g. in a gantry
• CPC Class Codes: A61B 2034/742 Joysticks
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• 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 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 25/0158 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 positioned. A Virtual Tip serves as an operator control. Movement of the operator control produces corresponding movement of the magnetic tip inside the patient'"'"'s body. Additionally, the control provides tactile feedback to the operator'"'"'s hand in the appropriate axis or axes if the magnetic tip encounters an obstacle. The output of the control combined with the magnetic tip position and orientation feedback allows a servo system to control the external magnetic field by pulse width modulating the positioning electromagnet. Data concerning the dynamic position of a moving body part such as a beating heart offsets the servo systems response in such a way that the magnetic tip, and hence the secondary tool is caused to move in unison with the moving body part.

Claims

1. An apparatus for controlling the movement of a surgical tool to be inserted into the body of a patient, comprising;

a controllable magnetic field source having a first cluster of electromagnet poles and a second cluster of electromagnet 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, wherein said distal end comprises a magnetic element positioned longitudinally therein, said magnetic element comprising a proximal pole and a distal pole;

a servo system that controls said location of said distal end of the tool with said controllable magnetic field source by continuously and automatically altering the magnetic field source without any external input from a user;

one or more magnetic field sensors configured to sense a current position of said proximal pole and said distal pole of said magnetic element in said distal end of the tool wherein the current position of the magnetic element is determined based on the magnitude of a resultant force vector (B) generated by the controllable magnetic field source and further based on the direction of the force vector B;

wherein the magnitude of the resultant force vector B is determined from three orthogonal components (Bx, By, Bz) associated with at least six electromagnets wherein the magnitude of the force vector B is given by the equation;

B=square root(Bx²+By²+Bz²),

and wherein the direction of the force vector B is determined with at least three resultant angles between the three orthogonal components with the following equations;

α

=(cos<sup>−

1</sup> Bx)/B, β

=(cos<sup>−

1</sup> By)/B, δ

=(cos<sup>−

1</sup> Bz)/B;

an auxiliary device comprising at least one of the group consisting of;

an x-ray device, an ultrasound device, and a radar device, wherein said auxiliary device is configured to obtain dynamic position data concerning a dynamic position of an organ of a patient corresponding to a desired position of said distal end of the tool;

a system controller that is configured to process said dynamic position data of said organ obtained by said auxiliary device, and said current position of said proximal pole and said distal pole of said distal end of the tool obtained by said magnetic field sensors to compute a position error between said desired position of said distal end of the tool and said current position of said distal end of the tool, such that said system controller computes said position error to compensate for said dynamic position of said organ, and wherein said system controller is further configured to continuously and automatically alter the magnitude and direction of the controllable magnetic field source using the servo system based on the position error data such that said distal end of the tool continuously and automatically moves substantially in unison with a continuous natural motion of said organ, wherein the controllable magnetic field is altered without any external input from the user; and

a user control device to provide user inputs to said system controller wherein said system controller provides tactile feedback to the user through said user control device when said position error exceeds a predetermined value while simultaneously compensating for said dynamic position as said distal end of the tool moves substantially in unison with the continuous natural motion of said organ.

2. The apparatus of claim 1, said distal end of the tool comprises one or more piezoelectric rings.

3. The apparatus of claim 1, said distal end of the tool comprises one or more piezoelectric rings for providing sensor data to the system controller.

4. The apparatus of claim 1, further comprising an operator interface unit.

5. The apparatus of claim 1, wherein said first cluster of poles is connected to said second cluster of poles by a magnetic material.

6. The apparatus of claim 1, further comprising:

a Virtual Tip Calibration Fixture.

7. The apparatus of claim 1, further comprising:

a communication controller;

a calibration fixture; and

one or more temperature sensors.

8. The apparatus of claim 1, wherein said one or more sensors comprises one or more temperature sensors paired with the one or more magnetic field sensors.