# US 2019/0314616 A1 · System and method for endoluminal and translumenal therapy

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- Number: US 2019/0314616 A1
- Document ID: US20190314616A1
- Status: Published application
- Kind: A1
- Application number: 16/431,321
- Filed: 2019-06-04
- Published: 2019-10-17
- Earliest claimed: 2011-01-20
- Assignees: Auris Health, Inc.
- Applicants: Auris Health, Inc.
- Inventors: Frederic H. Moll; Randall L. Schlesinger; Farzad Soleimani; Daniel T. Wallace
- Web page: https://patentgrep.com/patent/US20190314616A1

## CPC

- 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})
- A61B 5/0066: {Optical coherence imaging}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 34/30: Surgical robots
- A61B 1/307: for the urinary organs, e.g. urethroscopes or cystoscopes
- A61B 5/062: {using magnetic field}
- 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}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61B 2017/00053: {Mapping}
- A61B 2017/00256: {Creating an electrical block}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00285: {Balloons}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00517: {Urinary bladder or urethra}
- A61B 2018/00577: {Ablation}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/1405: {Electrodes having a specific shape}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2018/1861: {with an instrument inserted into a body lumen or cavity, e.g. a catheter}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/2046: {Tracking techniques}
- A61B 2034/2061: {using shape-sensors, e.g. fiber shape sensors with Bragg gratings}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2034/302: {specifically adapted for manipulations within body cavities, e.g. within abdominal or thoracic cavities}
- A61B 2034/303: {specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels}
- A61B 2090/364: {Correlation of different images or relation of image positions in respect to the body}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim at position 1

1-17. (canceled)

### Claim 18

A catheter system for performing a medical procedure, comprising:
a sheath instrument configured to be advanced within a patient, the sheath instrument comprising a proximal portion, a distal portion, and a sheath wall that surrounds and forms a guide insertion lumen;
a guide instrument configured to be advanced through the guide insertion lumen, the guide instrument comprising a proximal portion, a distal portion, and a guide wall that surrounds and forms a pre-shaped instrument lumen; and
a pre-shaped instrument configured to be advanced through the pre-shaped instrument lumen, the pre-shaped instrument comprising a curved proximal end and extending from the proximal portion of the guide instrument; and
wherein, in use, the pre-shaped instrument is advanced to a target site via the pre-shaped instrument lumen to perform the medical procedure.

### Claim 19 (depends on 18)

The catheter system of claim 18, wherein the curved proximal end of the pre-shaped instrument comprises a J-curve shape.

### Claim 20 (depends on 18)

The catheter system of claim 18, wherein the curved proximal end of the pre-shaped instrument comprises an electrode, the electrode configured to create a lesion at the target site when a current flows through the electrode.

### Claim 21 (depends on 20)

The catheter system of claim 20, wherein the pre-shaped instrument is configured to be withdrawn to create an elongate lesion within the target site.

### Claim 22 (depends on 21)

The catheter system of claim 21, wherein the current discontinuously flows through the electrode as the pre-shaped instrument is withdrawn.

### Claim 23 (depends on 21)

The catheter system of claim 21, wherein the current continuously flows through the electrode as the pre-shaped instrument is withdrawn.

### Claim 24 (depends on 21)

The catheter system of claim 21, wherein the elongate lesion comprises a linear or curvy pattern.

### Claim 25 (depends on 18)

The catheter system of claim 18, wherein the curved proximal end of the pre-shaped instrument comprises a spiral or helical shape.

### Claim 26 (depends on 18)

The catheter system of claim 18, wherein the pre-shaped instrument is coupled to a hypotube.

### Claim 27 (depends on 26)

The catheter system of claim 26, wherein the pre-shaped instrument is coupled to the hypotube via a metallic crimping coupler.

### Claim 28 (depends on 18)

The catheter system of claim 18, further comprising a restraining tube configured to radially collapse the curved proximal end of the pre-shaped instrument as the pre-shaped instrument is advanced through the pre-shaped instrument lumen, the restraining tube further configured to be removed from the curved proximal end to allow the curved proximal end to radially expand.

### Claim 29 (depends on 18)

The catheter system of claim 18, wherein the catheter is used for a renal plexus denervation or a renal neuroplexus diagnostic procedure.

### Claim 30 (depends on 18)

The catheter system of claim 18, wherein the sheath instrument and the guide instrument are configured to be controlled robotically by the catheter system.

### Claim 31 (depends on 18)

The catheter system of claim 18, wherein the pre-shaped instrument are configured to be controlled robotically by the catheter system.

### Claim 32

A method for performing a medical procedure using a robotic catheter system, the method comprising:
advancing a sheath instrument within a patient, the sheath instrument comprising a proximal portion, a distal portion, and a sheath wall that surrounds and forms a guide insertion lumen;
advancing a guide instrument through the guide insertion lumen, the guide instrument comprising a proximal portion, a distal portion, and a guide wall that surrounds and forms a pre-shaped instrument lumen, the guide instrument extending from the proximal portion of the sheath instrument;
advancing a pre-shaped instrument through the pre-shaped instrument lumen, the pre-shaped instrument comprising a curved proximal end, the pre-shaped instrument extending from the proximal portion of the guide instrument; and
advancing the pre-shaped instrument to a target site to perform a medical procedure.

### Claim 33 (depends on 32)

The method of claim 32, wherein the curved proximal end of the pre-shaped instrument comprises a spiral or helical shape.

### Claim 34 (depends on 32)

The method of claim 32, wherein the pre-shaped instrument is coupled to a hypotube.

### Claim 35 (depends on 32)

The method of claim 32, wherein the medical procedure comprises renal plexus denervation or a renal neuroplexus diagnostic procedure.

### Claim 36 (depends on 32)

The method of claim 32, wherein advancing the sheath instrument and advancing the guide instrument are performed robotically by the robotic catheter system.

### Claim 37 (depends on 32)

The method of claim 32, wherein advancing the pre-shaped instrument is performed robotically by the robotic catheter system.
