Process for percutaneous operations

• US 10,639,108 B2
• Filed: 10/31/2016
• Issued: 05/05/2020
• Est. Priority Date: 10/30/2015
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Auris Health, Inc. (Johnson & Johnson)
• Inventors: Romo, Enrique, Schummers, David M., Mintz, David S.
• Primary Examiner(s): Newton, Alexandra L
• Assistant Examiner(s): Boler, Rynae
• Application Number:
  US15/339,484
• Publication Number:
  US 20170119481A1
• Time in Patent Office: 1,282 Days
• Field of Search: 606127, 600139
• CPC Class Codes: A61B 1/00045 Display arrangement
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00149 using articulated arms
• CPC Class Codes: A61B 1/0016 using motor drive units
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/26 for producing a shock wave, e.g. laser lithotripsy
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00991 : Telescopic means
• CPC Class Codes: A61B 2017/2212 : having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 : having an open distal end
• CPC Class Codes: A61B 2017/320008 : Scrapers
• CPC Class Codes: A61B 2018/00511 : Kidney
• CPC Class Codes: A61B 2018/00517 : Urinary bladder or urethra
• CPC Class Codes: A61B 2034/102 : Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 : Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 : Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 : Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2065 : Tracking using image or pattern recognition
• CPC Class Codes: A61B 2034/254 : being adapted depending on the stage of the surgical procedure
• 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 2034/302 : specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities
• CPC Class Codes: A61B 2034/742 : Joysticks
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• 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 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 34/30 : Surgical robots
• CPC Class Codes: A61B 34/71 : Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 34/74 : Manipulators with manual electric input means
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms

Abstract

A method is described for performing a percutaneous operation on a patient to remove an object from a cavity within the patient. The method includes advancing a first alignment sensor into the cavity through a patient lumen. The first alignment sensor provides its position and orientation in free space in real time. The alignment sensor is manipulated until it is located in proximity to the object. A percutaneous opening is made in the patient with a surgical tool, where the surgical tool includes a second alignment sensor that provides the position and orientation of the surgical tool in free space in real time. The surgical tool is directed towards the object using data provided by both the first and the second alignment sensors.

Claims

1. A method for performing a percutaneous operation on a patient, comprising:

advancing a first alignment sensor on a distal tip of an endoscope into a cavity through a patient lumen, the first alignment sensor providing the position and orientation of the alignment sensor in free space in real time, wherein advancing the first alignment sensor on the distal tip of the endoscope into the cavity comprises actuating a robotic arm of a surgical robotic system in response to an input at a control module of the surgical robotic system;

manipulating the first alignment sensor until the first alignment sensor is located in proximity to an object to be removed from the cavity;

making a percutaneous opening in the patient with a surgical tool comprising a second alignment sensor that provides the position and orientation of the surgical tool in free space in real time;

receiving, at a computer system for the robotic surgical system, data from the first and second alignment sensors;

providing, via a display device, a graphical interface displaying one or more graphical elements representing the orientation of the surgical tool relative to the distal tip based on the data from the first and second alignment sensors; and

directing the surgical tool including the second alignment sensor through the percutaneous opening and towards the object using the graphical elements.

2. The method of claim 1, wherein the distal tip comprises a camera to capture images of a field of view of the distal tip and the first alignment sensor.

3. The method of claim 2 wherein manipulating the first alignment sensor until the first alignment sensor is located in proximity to the object comprises:

manipulating the distal tip of the endoscope until the object appears in the field of view of the camera.

4. The method of claim 1 wherein advancing the first alignment sensor into the cavity comprises:

advancing a guide wire into the cavity, the guide wire comprising the first alignment sensor.

5. The method of claim 4 wherein manipulating the first alignment sensor until the first alignment sensor is located in proximity to the object comprises:

performing fluoroscopy on the patient to generate fluoroscopic data including a location of the guide wire and first alignment sensor in the patient; and

manipulating the guide wire until the first alignment sensor is in proximity with the object based on the fluoroscopic data.

6. The method of claim 1, wherein advancing the first alignment sensor into the cavity comprises:

advancing a ureteroscope into the cavity, the ureteroscope comprising a working channel; and

advancing a guide wire past the distal tip of the ureteroscope.

7. The method of claim 1, wherein the first and second alignment sensors are electromagnetic (EM) sensors that receive EM fields emitted by a plurality of EM field generators placed in proximity to the patient.

8. The method of claim 7, wherein each of the EM sensors comprises at least one coil of conductive material.

9. The method of claim 7, further comprising:

obtaining a three dimensional (3D) representation of an internal structure of the patient; and

registering data received from the first alignment sensor to the 3D representation to determine a frame of reference for the data that aligns with a position and orientation of the patient in free space.

10. The method of claim 9, wherein the 3D representation is a CT scan.

11. The method of claim 9, further comprising:

segmenting the 3D representation to identify landmarks; and

registering locations of the landmarks with one or more alignment sensors to determine the frame of reference.

12. The method of claim 9, wherein registering the data comprises:

aggregating the locations of the landmarks into at least one point set; and

determining, based on point set, a homogeneous transformation comprising a rotation matrix and a translation vector.

13. The method of claim 12, wherein:

at least one of the landmarks is identifiable on an outside of the patient; and

the first alignment sensor used to register locations of the landmarks is navigated outside the patient to register the locations.

14. The method of claim 13:

wherein the first alignment sensor used to register locations of the landmarks is coupled to a hand-held implement.

15. The method of claim 12, wherein:

at least one of the landmarks is identifiable intra-operatively; and

the first alignment sensor used to register locations of the landmarks is navigated inside the patient to register the locations.

16. The method of claim 7, further comprising:

obtaining a three dimensional (3D) representation of an internal structure of the patient; and

navigating the first alignment sensor outside the patient to identify a first point set comprising locations of landmarks identifiable outside the patient;

navigating a second alignment sensor inside the patient to identify a second point set comprising locations of landmarks identifiable inside the patient;

registering the first and second point sets to the 3D representation to determine a frame of reference for the data that aligns with a position and orientation of the patient in free space.

17. The method of claim 1, wherein each alignment sensor is electrically coupled to a conductive wire which transmits sensor data to a computing system for processing.

18. The method of claim 1, further comprising updating the display of a first graphical element in the graphical interface in response to motion of the distal tip of the endoscope within the patient.

19. The method of claim 18, further comprising updating the display of a second graphical element in the graphic interface in response to motion of the surgical tool within the patient.

20. The method of claim 1, further comprising providing a notification that the surgical tool has arrived at the object responsive to the first and the second alignment sensors being in sufficiently close proximity.

21. The method of claim 3, wherein the steps of advancing the distal tip of the endoscope, manipulating the distal tip of the endoscope, and making the percutaneous opening, are controlled by a plurality of robotic arms.

22. The method of claim 2, wherein advancing the distal tip of the endoscope comprises:

actuating a plurality of robotic arms in response to the input, the actuation of the robotic arms advancing the distal tip of the endoscope.

23. The method of claim 1, wherein advancing the surgical tool comprises:

receiving a second input at a control module; and

actuating a plurality of robotic arms in response to the input, the actuation of the robotic arms directing the surgical tool.

24. The method of claim 1, wherein the surgical tool is a needle comprising a balloon, the method further comprising:

inflating the balloon to create a port into the patient cavity; and

inserting a suction tube into the port, the suction tube having a diameter sufficient to remove the object or fragments thereof.

25. The method of claim 24, the method further comprising:

advancing the endoscope into the cavity through a patient lumen other than the port, the endoscope comprising a working channel;

irrigating the patient cavity with a fluid, where the fluid passes within the working channel of the endoscope; and

applying negative pressure to the suction tube, the combination of the fluid irrigation and the negative pressure assisting in causing the object to be removed from the cavity through the suction tube.

26. The method of claim 25, the method further comprising at least one of:

passing an optical fiber or a laser through the working channel and activating the optical fiber or laser to perform lithotripsy on the object to break it apart; and

passing an endoscopic tool through the working channel and manipulating the endoscopic tool to position the object to be removed from the cavity through the suction tube.

27. The method of claim 26, wherein the endoscopic tool is at least one of a basket apparatus and a grasper.

28. The method of claim 1 wherein the object is at least one from the group consisting of:

a kidney stone or a bladder stone, a stone formed from at least one of calcium, magnesium, ammonia, uric acid, and cysteine.

29. The method of claim 1, wherein the cavity is a kidney of a patient or a calyx within the kidney of the patient.