System and method for endoluminal and translumenal therapy

• US 10,350,390 B2
• Filed: 06/06/2016
• Issued: 07/16/2019
• Est. Priority Date: 01/20/2011
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Auris Health, Inc. (Johnson & Johnson)
• Inventors: Moll, Frederic H., Schlesinger, Randall L., Soleimani, Farzad, Wallace, Daniel T.
• Primary Examiner(s): Malamud, Deborah L
• Application Number:
  US15/174,384
• Publication Number:
  US 20160279394A1
• Time in Patent Office: 1,135 Days
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• 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 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00256 Creating an electrical block
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2046 Tracking techniques
• CPC Class Codes: A61B 2034/2061 : using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• 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 2034/303 : specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels
• CPC Class Codes: A61B 2090/364 : Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 34/10 : Computer-aided planning, simulation or modelling of surgical operations
• 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 34/30 : Surgical robots
• CPC Class Codes: A61B 5/0066 : Optical coherence imaging
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 : Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/062 : using magnetic field
• CPC Class Codes: A61B 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/14546 : for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/201 : Assessing renal or kidney functions
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A system for conducting denervation of the neural plexus adjacent the renal artery, comprises a pre-shaped ablative element operatively coupled to an elongate deployment member configured to be navigated into the renal artery, the pre-shaped ablative element comprising one or more RF electrodes disposed in an arcuate pattern; and an energy source operatively coupled to the one or more RF electrodes and being configured to cause current to flow from the pre-shaped ablative element and cause localized heating sufficient to denervate nearby neural tissue.

Claims

1. A method for performing a medical procedure using a robotic catheter system, the method comprising:

advancing, within a blood vessel of a patient, a sheath instrument comprising a sheath wall that surrounds and forms a guide insertion lumen, the sheath instrument extending along a longitudinal axis from a proximal portion to a distal portion, the sheath instrument comprising a balloon coupled to the distal portion, wherein a drain lumen extends through at least a portion of the balloon or sheath instrument;

inflating the balloon, wherein following inflation, blood flow of the blood vessel continues through the drain lumen;

advancing a guide instrument through the guide insertion lumen, the guide insertion lumen extending from the proximal portion along the longitudinal axis and further extending radially away from the longitudinal axis toward the sheath wall and terminating at a guide insertion port that extends through a balloon wall of the balloon to, in use, face an inner wall of the blood vessel;

advancing the guide instrument through the guide insertion port and a wall of the blood vessel to create a transvascular access port;

advancing the guide instrument and a diagnostic or interventional instrument to a target site to perform a medical procedure; and

retracting the guide instrument and the diagnostic or interventional instrument and closing the transvascular access port prior to deflation of the balloon and removal of the sheath instrument.

2. The method of claim 1, wherein the medical procedure comprises renal plexus denervation or a renal neuroplexus diagnostic procedure.

3. The method of claim 1, wherein the blood vessel is selected from a group consisting of the patient'"'"'s:

celiac trunk artery, superior mesentary artery, vena cava, and renal vein.

4. The method of claim 1, wherein the drain lumen extends through at least a portion of the sheath instrument.

5. The method of claim 1, wherein the drain lumen extends through at least the balloon.

6. The method of claim 1, wherein the guide insertion port is positioned on a side of the balloon wall that faces radially away from the longitudinal axis.

7. The method of claim 1, wherein the balloon is inflated until the blood vessel is occluded except for the blood flowing through the drain lumen.

8. The method of claim 1, further comprising advancing a tool through the guide insertion lumen, the guide insertion port, and the wall of the blood vessel.

9. The method of claim 8, wherein the tool comprises a needle, wire, or dilator.

10. The method of claim 9, wherein the guide instrument is advanced over the tool using the working lumen of the guide instrument in an over-the-wire technique.

11. The method of claim 1, wherein advancing the sheath instrument and advancing the guide instrument are performed robotically by the robotic catheter system.

12. The method of claim 1, wherein advancing the diagnostic or interventional instrument is performed robotically by the robotic catheter system.

13. The method of claim 1, wherein the sheath instrument and guide instrument are steerable catheters.

14. The method of claim 1, wherein the diagnostic or interventional instrument is coupled to the guide instrument.

15. The method of claim 1, wherein the diagnostic or interventional instrument comprises a radiofrequency electrode, a cryoablation reservoir, a high intensity focused ultrasound treatment transducer, or a laser.

16. The method of claim 1, wherein closing the transvascular access port comprises closing the transvascular access port with a closure clip.

17. The method of claim 1, further comprising tracking a position or shape of a distal portion of at least one of the sheath instrument and the guide instrument using a localization system.

18. A method for performing a medical procedure using a robotic catheter system, the method comprising:

advancing, within a blood vessel of a patient, a sheath instrument having a balloon coupled to a distal portion of the sheath instrument, wherein a drain lumen extends through at least a portion of the balloon member or sheath instrument, and wherein a guide insertion lumen extends through the sheath instrument and terminates at a guide insertion port that extends through the balloon;

inflating the balloon, wherein following inflation, blood flow of the blood vessel continues through the drain lumen;

advancing a guide instrument through the guide insertion lumen, the guide insertion port, and a wall of the blood vessel to create a transvascular access port;

advancing the guide instrument and a diagnostic or interventional instrument to a target site to perform a medical procedure; and

retracting the guide instrument and the diagnostic or interventional instrument and closing the transvascular access port prior to deflation of the balloon and removal of the sheath instrument,

wherein the medical procedure comprises renal plexus denervation or a renal neuroplexus diagnostic procedure.

19. The method of claim 18, further comprising advancing a tool through the guide insertion lumen, the guide insertion port, and the wall of the blood vessel.

20. The method of claim 19, wherein the tool comprises a needle, wire, or dilator.