US-12620101-B2 - Systems, methods and devices for forming respiratory-gated point cloud for four dimensional soft tissue navigation

Abstract

A surgical instrument navigation system and method of use 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.

Inventors

• Troy L. Holsing
• Mark Hunter

Assignees

• VERAN MEDICAL TECHNOLOGIES, LLC

Dates

Publication Date

20260505

Application Date

20231020

Claims (18)

1. 1 . A surgical catheter, comprising: 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; the distal end portion defining an auger housing, the auger housing defining a tissue collection region and an exit opening; an auger device housed within the auger housing comprises an auger bit and an actuation wire operatively connected thereto, the actuation wire extends proximally from within the auger housing to the handle, the auger device is actuatable between a first position within the auger housing through the exit opening to a second extended position outside the auger housing.
2. 2 . The surgical catheter of claim 1 , wherein the auger bit is helical in shape.
3. 3 . The surgical catheter of claim 1 , wherein the auger bit comprises a proximal base and a distal tip, the auger bit having a constant diameter from the proximal base to the distal tip.
4. 4 . The surgical catheter of claim 1 , wherein the auger bit comprises a proximal base and a distal tip, the auger bit having a diameter, the diameter decreasing from the proximal base to the distal tip.
5. 5 . The surgical catheter of claim 1 , wherein a portion of the tissue collection region comprises a viewing window.
6. 6 . The surgical catheter of claim 1 , further comprising a localization element located at the distal end portion.
7. 7 . The surgical catheter of claim 6 , wherein the localization element is affixed to the actuation wire.
8. 8 . The surgical catheter of claim 6 , wherein the localization element is positioned proximate to the auger device, and that the auger device and the localization element move in conjunction with one another upon actuation of the auger device.
9. 9 . The surgical catheter of claim 6 , wherein the localization element comprises an electromagnetic sensor.
10. 10 . The surgical catheter of claim 9 , wherein the electromagnetic sensor is a six (6) degree of freedom electromagnetic sensor.
11. 11 . The surgical catheter of claim 1 , wherein the exit opening is located at a distal tip of the auger housing.
12. 12 . The surgical catheter of claim 1 , wherein the exit opening is an opening in the outer wall.
13. 13 . The surgical catheter of claim 1 , further comprising a radiopaque marker pattern, the radiopaque marker pattern located at the distal end portion of the elongate flexible shaft.
14. 14 . The surgical catheter of claim 13 , wherein the radiopaque marker pattern is comprised of a plurality of longitudinally spaced apart radiopaque markers.
15. 15 . The surgical catheter of claim 14 , wherein each of the plurality of longitudinally spaced apart radiopaque markers is circular shaped.
16. 16 . The surgical catheter of claim 1 , wherein the distal end portion of the elongate flexible shaft defines an echogenic pattern.
17. 17 . The surgical catheter of claim 16 , wherein the echogenic pattern is defined by a plurality of grooves.
18. 18 . The surgical catheter of claim 16 , wherein the echogenic pattern is defined by a plurality of partially spherical indentations.

Description

FIELD OF INVENTION The present invention generally relates to devices and methods associated with a medical procedure, and, in one embodiment, to medical devices for use in and methods associated with the respiratory system. BACKGROUND Image guided surgery (IGS), also known as image guided intervention (IGI), enhances a physician's ability to locate instruments within a patient's anatomy during a medical procedure. IGS can include 2-dimensional (2D), 3-dimensional (3D), and 4-dimensional (4D) applications. The fourth dimension of IGS can include multiple parameters either individually or together such as time, motion, electrical signals, pressure, airflow, blood flow, respiration, heartbeat, and other patient measured parameters. Existing imaging modalities can capture the movement of dynamic anatomy. Such modalities include electrocardiogram (ECG)-gated or respiratory-gated magnetic resonance imaging (MRI) devices, ECG-gated or respiratory-gated computer tomography (CT) devices, standard computed tomography (CT), 3D Fluoroscopic images (Angio-suites), and cinematography (CINE) fluoroscopy and ultrasound. Multiple image datasets can be acquired at different times, cycles of patient signals, or physical states of the patient. The dynamic imaging modalities can capture the movement of anatomy over a periodic cycle of that movement by sampling the anatomy at several instants during its characteristic movement and then creating a set of image frames or volumes. Although significant improvements have been made in these fields, a need remains for improved medical devices and procedures for visualizing, accessing and manipulating a targeted anatomical tissue. SUMMARY OF THE INVENTION Among the various aspects of the present invention may be noted devices for use in and methods associated with medical procedures; such devices and methods, for example, may include devices and methods that enhance a physician's ability to locate instruments within anatomy during a medical procedure, such as image guided surgery (IGS) or image guided intervention (IGI) and such devices and methods may further include devices and methods that facilitate accessing and manipulating a targeted anatomical tissue. Briefly, therefore, one aspect of the present invention is a method for modifying or deforming a segmented image dataset for a region of a respiratory system of a patient to the corresponding anatomy of a patient's respiratory system. The method comprises (i) forming a respiratory-gated point cloud of data that demarcates anatomical features in a region of a patient's respiratory system at one or more discrete phases within a respiration cycle of a patient, (ii) density filtering the respiratory-gated point cloud, (iii) classifying the density filtered respiratory-gated point cloud according to anatomical points of reference in a segmented image dataset for the region of the patient's respiratory system, and (iv) modifying the segmented image dataset to correspond to the classified anatomical points of reference in the density filtered respiratory-gated point cloud. Another aspect of the present invention is a method of preparing a segmented image dataset to match the anatomy of a patient's respiratory system. The method comprises forming a respiratory-gated point cloud of data that demarcates anatomical features in a region of a patient's respiratory system at one or more discrete phases within a respiration cycle of a patient. The method further comprises density filtering the respiratory-gated point cloud, classifying the density filtered respiratory-gated point cloud according to anatomical points of reference in a segmented image dataset for the region of the patient's respiratory system, registering the classified respiratory-gated point cloud to the segmented image dataset, comparing the registered respiratory-gated point cloud to a segmented image dataset to determine the weighting of points comprised by the classified respiratory-gated point cloud, distinguishing regions of greater weighting from regions of lesser weighting and modifying the segmented image dataset to correspond to the classified respiratory-gated point cloud. A further aspect of the present invention is a method for simulating the movement of a patient's respiratory system during respiration. The simulation method comprises (i) forming a respiratory-gated point cloud of data that demarcates anatomical features in a region of a patient's respiratory system at one or more discrete phases within a respiration cycle of a patient, (ii) density filtering the respiratory-gated point cloud, (iii) classifying the density filtered respiratory-gated point cloud according to anatomical points of reference in a segmented image dataset for the region of the patient's respiratory system, (iv) creating a cine loop comprising a plurality of modified segmented image datasets through multiple modifications of the segmented image dataset to correspond to a plurality of clas