System and method for endoluminal and translumenal therapy

• US 9,358,076 B2
• Filed: 04/13/2015
• Issued: 06/07/2016
• Est. Priority Date: 01/20/2011
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Moll, Frederic H., Schlesinger, Randall L., Soleimani, Farzad, Wallace, Daniel T.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/685,089
• Publication Number:
  US 20150209112A1
• Time in Patent Office: 421 Days
• US Class Current: 1/1
• 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 ablating a nerve adjacent a renal artery, the method comprising:

navigating a pre-shaped ablative element positioned at or near a distal end of a flexible, robotic, electromechanically steerable catheter into the renal artery in a collapsed configuration, using one or more control elements coupled to a proximal end of the steerable catheter;

imaging targeted portions of the nerve from inside the renal artery to create an anatomic map of the targeted portions;

using the anatomical map to create thereon an electrical map of the targeted portions relative to the renal artery, to assist in identification of selective denervation treatment locations within a renal plexus adjacent the renal artery;

causing the pre-shaped ablative element to assume an expanded configuration within the renal artery to contact an inner wall of the renal artery in a pattern configured to address the targeted portions, based at least in part on the anatomic map and the electrical map;

passing a current through the pre-shaped ablative element to ablate the nerve; and

monitoring progress of ablation of the nerve, using the pre-shaped ablative element and the electrical map.

2. The method of claim 1, wherein the steerable catheter comprises a coaxially-associated catheter configured to move in response to control signals from a master input device configured to be manually operated by an operator.

3. The method of claim 1, wherein creating an electrical map comprises:

stimulating a first portion of the nerve; and

detecting conduction of the stimulation at a second portion of the nerve longitudinally displaced from the first portion.

4. The method of claim 3, further comprising associating a first nerve anatomical location with the first portion of the nerve and a second nerve anatomical location with the second portion of the nerve.

5. The method of claim 4, further comprising associating a renal artery anatomical location from the anatomic map with each of the nerve anatomical locations to form an electroanatomical map.

6. The method of claim 1, wherein the treatment pre-shaped ablative element comprises a radiofrequency electrode, and wherein passing the current through the ablative element comprises passing current through the electrode.

7. The method of claim 1, further comprising advancing the pre-shaped ablative element relative to the distal portion of the steerable catheter.

8. The method of claim 1, wherein creating an electrical map comprises stimulating a first portion of the nerve and detecting conduction of the stimulation in a portion of a neural plexus associated with the nerve.

9. The method of claim 1, further comprising moving the pre-shaped ablative element relative to the targeted portions while passing current through the pre-shaped ablative element to ablate an elongate portion of the nerve.

10. The method of claim 9, wherein the moving is actuated by manual or electromechanical pullback of the pre-shaped ablative element.