SURGICAL CATHETER HAVING SIDE EXITING MEDICAL INSTRUMENT AND RELATED SYSTEMS AND METHODS FOR FOUR DIMENSIONAL SOFT TISSUE NAVIGATION

• US 20130225942A1
• Filed: 02/22/2013
• Published: 08/29/2013
• Est. Priority Date: 02/22/2012
• Status: Active Grant

• Current Assignee: Veran Medical Technologies, Inc. (Olympus Corporation)
• Original Assignee: Veran Medical Technologies, Inc. (Olympus Corporation)
• Inventors: HOLSING, Troy L., HUNTER, Mark, STERN, Evan
• Granted Patent: US 10,249,036 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00694 with means correcting for movement of or for synchronisation with the body
• CPC Class Codes: A61B 2017/00699 correcting for movement caused by respiration, e.g. by triggering
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320775 : Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2018/00541 : Lung or bronchi
• CPC Class Codes: A61B 2034/2051 : Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2061 : using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• CPC Class Codes: A61B 2034/2072 : Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/364 : Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3925 : ultrasonic
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• 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 5/0066 : Optical coherence imaging
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/061 : 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 A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 : using magnetic field
• CPC Class Codes: A61B 5/11 : Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/113 : occurring during breathing
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 5/725 : using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61B 5/7264 : Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7285 : for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/7292 : Prospective gating, i.e. predicting the occurrence of a physiological event for use as a synchronisation signal
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 6/032 : Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 : involving fluorescence X-ray imaging
• CPC Class Codes: A61B 6/487 : involving fluoroscopy
• CPC Class Codes: A61B 6/5223 : generating planar views from image data, e.g. extracting a coronal view from a 3D image
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 8/483 : involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61N 5/1007 : Arrangements or means for the introduction of sources into the body
• CPC Class Codes: G06T 1/00 : General purpose image data processing
• CPC Class Codes: G06T 11/60 : Editing figures and text; Combining figures or text
• CPC Class Codes: G06T 19/00 : Manipulating 3D models or images for computer graphics
• CPC Class Codes: G06T 2200/28 : involving image processing hardware
• CPC Class Codes: G06T 2207/10028 : Range image; Depth image; 3D point clouds
• CPC Class Codes: G06T 2207/10088 : Magnetic resonance imaging [MRI]
• CPC Class Codes: G06T 2207/10121 : Fluoroscopy
• CPC Class Codes: G06T 2207/10132 : Ultrasound image
• CPC Class Codes: G06T 2207/20124 : Active shape model [ASM]
• CPC Class Codes: G06T 2207/30061 : Lung
• CPC Class Codes: G06T 2210/41 : Medical
• CPC Class Codes: G06T 2210/56 : Particle system, point based geometry or rendering
• CPC Class Codes: G06T 7/0012 : Biomedical image inspection
• CPC Class Codes: G06T 7/11 : Region-based segmentation
• CPC Class Codes: G06T 7/12 : Edge-based segmentation
• CPC Class Codes: G06T 7/149 : involving deformable models, e.g. active contour models
• CPC Class Codes: G06T 7/33 : using feature-based methods

Abstract

A surgical instrument navigation system is provided that visually simulates a virtual volumetric scene of a body cavity of a patient from a point of view of a surgical instrument residing in the cavity of the patient, wherein the surgical instrument, as provided, may be a steerable surgical catheter with a biopsy device and/or a surgical catheter with a side-exiting medical instrument, among others. Additionally, systems, methods and devices are provided for forming a respiratory-gated point cloud of a patient'"'"'s respiratory system and for placing a localization element in an organ of a patient.

Claims

1. A surgical catheter for navigated surgery, comprising:

an elongate flexible shaft having a proximal end portion, an opposite distal end portion, a longitudinal axis, a side exit in the distal end portion, and an outer wall extending from the proximal end portion to the distal end portion;

a handle attached to the proximal end portion;

an electromagnetic localization element at the distal end portion; and

a medical instrument housed within the elongate flexible shaft that is extendable along a path from a position within the outer wall and through the side exit to an extended position outside the outer wall, the medical instrument being disposed at an angle of at least 10 degrees relative to the longitudinal axis at the side exit when in the extended position, wherein the position of the medical instrument along the path can be calibrated to the location of the electromagnetic localization element and displayed by a surgical instrument navigation system.

2. The surgical catheter of claim 1 wherein the elongate flexible shaft comprises a steering mechanism comprising a steering actuator at the proximate end portion and a pull wire connected to the steering actuator wherein the distal end portion may be moved relative to the proximal end portion by manipulating the steering actuator to apply a tension to the pull wire.

3. The surgical catheter of claim 2 wherein an arc of at least 20 degrees may be introduced into the elongate flexible shaft by manipulation of the steering actuator.

4. The surgical catheter of claim 2 wherein an arc of at least 120 degrees may be introduced into the elongate flexible shaft by manipulation of the steering actuator.

5. The surgical catheter of claim 4 wherein manipulation of the steering actuator to introduce an arc of at least 120 degrees into the elongate flexible shaft causes the distal end portion to move such that a distance of no more than 1 inch separates two regions of the elongate flexible shaft located at opposing ends of a chord connecting two points separated by at least 120 degrees on the arc.

6. The surgical catheter of claim 2 wherein an arc of at least 180 degrees may be introduced into the elongate flexible shaft by manipulation of the steering actuator.

7. The surgical catheter of claim 6 wherein manipulation of the steering actuator to introduce an arc of at least 180 degrees into the elongate flexible shaft causes the distal end portion to move such that a distance of no more than 1 inch separates two regions of the elongate flexible shaft located at opposing ends of a chord connecting two points separated by at least 180 degrees on the arc.

8. The surgical catheter of claim 1 wherein said electromagnetic localization element comprises a six (6) degree of freedom electromagnetic sensor or a five (5) degree of freedom electromagnetic sensor.

9. The surgical catheter of claim 1 wherein said elongate flexible shaft further comprises a series of markers detectable by a fluoroscopic imaging device.

10. The surgical catheter of claim 1 wherein said elongate flexible shaft is echogenic.

11. The surgical catheter of claim 1 wherein said distal end portion further comprises a series of markers detectable by a fluoroscopic imaging device.

12. The surgical catheter of claim 1 wherein said distal end portion is echogenic.

13. The surgical catheter of claim 1 wherein the medical instrument is echogenic.

14. The surgical catheter of claim 1 wherein the medical instrument comprises a forceps device, an auger device, a boring bit device, a brush device, an aspiration needle, an ablation device, a fiducial delivery device, a radioactive seed delivery device, a drug delivery device, a cryogenic therapy delivery device, a radiofrequency emitter, a microwave emitter or a laser device.

15. The surgical catheter of claim 14 wherein the medical instrument further comprises a tissue collection region.

16. The surgical catheter of claim 15 wherein said tissue collection region further comprises a viewing window through which removed tissue can be inspected from outside the biopsy device.

17. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of at least 30 degrees relative to the longitudinal axis at the side exit.

18. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of at least 45 degrees relative to the longitudinal axis at the side exit.

19. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of at least 60 degrees relative to the longitudinal axis at the side exit.

20. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of at least 90 degrees relative to the longitudinal axis at the side exit.

21. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of at least 180 degrees relative to the longitudinal axis at the side exit.

22. The surgical catheter of claim 1 wherein the medical instrument in the extended position is disposed at an angle of about 30 to about 180 degrees relative to the longitudinal axis at the side exit.

23. The surgical catheter of claim 1 wherein the elongate flexible shaft has an outer diameter of less than 5 mm.

24. The surgical catheter of claim 1 wherein the surgical catheter further comprises removably attached offset devices to limit the extension of the medical instrument.

25. The surgical catheter of claim 1 wherein the biopsy device may be advanced a distance of at least 1 cm along the path manipulation of the handle.

26. The surgical catheter of claim 1 wherein the medical instrument comprises nitinol.

27. The surgical catheter of claim 1 wherein the medical device comprises stainless steel.

28. The surgical catheter of claim 1 wherein the medical device is flexible.

29. The surgical catheter of claim 1 wherein the medical instrument comprises a shape memory alloy.

30. The surgical catheter of claim 1 wherein the elongate flexible body comprises at least one sensing device in the distal end portion.

31. The surgical catheter of claim 30 wherein the sensing device is the sensing device is an electrode for sensing depolarization signals, a cardiac electrogram (EGM) signal sensor, an absolute pressure sensor, a physiological sensing device, a temperature sensor, a motion sensor, an optical coherence tomography sensor, a localization element, or an ultrasound sensor.

32. The surgical catheter of claim 30 wherein the sensing device detects the presence of absence of blood vessels.

33. A method of guiding a surgical catheter to a region interest of a patient, the method comprising:

displaying an image of the region of the patient;

inserting a flexible lumen into the region of the patient;

inserting a surgical catheter into the lumen, the surgical catheter comprising an electromagnetic localization element at the distal end portion;

navigating the surgical catheter to the region of interest;

detecting a location and orientation of the electromagnetic localization element;

displaying, in real-time, the medical instrument on the image by superimposing a virtual representation of the surgical catheter and the medical instrument on the image based upon the location and orientation of the electromagnetic localization element; and

performing a medical procedure at the region of interest.

34. The method of claim 33, wherein the surgical catheter further comprises:

an elongate flexible shaft having a proximal end portion, an opposite distal end portion, a longitudinal axis, and an outer wall extending from the proximal end portion to the distal end portion;

a handle attached to the proximal end portion; and

a medical instrument housed within the elongate flexible shaft that is extendable along a path from a position within the outer wall and through the side exit to an extended position outside the outer wall, the medical instrument being disposed at an angle of at least 10 degrees relative to the longitudinal axis at the side exit when in the extended position.