# US 9,433,760 B2 · Device and methods for nerve modulation using a novel ablation catheter with polymeric ablative elements

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- Number: US 9,433,760 B2
- Document ID: US9433760B2
- Status: Granted
- Kind: B2
- Application number: 13/711,231
- Filed: 2012-12-11
- Published: 2013-07-04
- Granted: 2016-09-06
- Earliest claimed: 2011-12-28
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Raj Subramaniam; Zaya Tun; Daniel J. Horn; Derek C. Sutermeister; James M. Anderson; Jeffrey S. Lindquist; Kent D. Harrison
- Web page: https://patentgrep.com/patent/US9433760B2

## CPC

- A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00)
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- 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 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00136: {with polymer}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/0022: {Balloons}
- A61B 2018/00238: {porous}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/1435: {Spiral}
- A61B 2018/147: {Electrodes transferring energy by capacitive coupling, i.e. with a dielectricum between electrode and target tissue}
- A61B 2018/1472: {for use with liquid electrolyte, e.g. virtual electrodes}
- A61B 2218/002: Irrigation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

The disclosure pertains to an intravascular catheter for nerve modulation, comprising an elongate member having a proximal end and a distal end, a balloon having a lumen and a balloon wall, the balloon wall comprising RF permeable sections and non-electrically conductive sections, an electrode disposed within the balloon and extending distally to the furthest distal RF permeable section. The RF permeable sections may comprise a plurality of RF permeable windows, each window having a greater circumferential dimension than an axial dimension. The intravascular system is suited for modulation of renal nerves.

## Claims

### Claim 1

An intravascular catheter, comprising:
an elongate member having a proximal end and a distal end;
a balloon having an interior surface, and exterior surface, a lumen defined by the interior surface and comprising three or more sections that are permeable to RF radiation extending from the interior surface of the balloon to the exterior surface of the balloon and at least one non-electrically conductive section; and
an electrode disposed in the balloon:
wherein the balloon comprises a first layer and a second laver; and
wherein the first layer is permeable to RF radiation and the second layer is non-electrically conductive.

### Claim 2 (depends on 1)

The intravascular catheter of claim 1, wherein the three or more sections that are permeable to RF radiation are spaced circumferentially and longitudinally with respect to each other.

### Claim 3 (depends on 1)

The intravascular catheter of claim 1, further comprising a temperature sensor.

### Claim 4 (depends on 1)

The intravascular catheter of any of claim 1, wherein the three or more sections that are permeable to RF radiation each comprise a hydrophilic polymer.

### Claim 5 (depends on 4)

The intravascular catheter of claim 4, wherein the hydrophilic polymer is hydrophilic polyurethane.

### Claim 6 (depends on 1)

The catheter of claim 1, wherein the three or more sections that are permeable to RF radiation each comprise the hydrophilic polymer blended with a second polymer.

### Claim 7 (depends on 6)

The catheter of claim 6, wherein the second polymer is selected from a group consisting of Pebax 6333, Pebax 7033, Pebax 7233, Nylon 12, Vestamid L2101F, Grilamid L20, and Grilamid L25.

### Claim 8 (depends on 7)

The catheter of claim 7, wherein the hydrophilic polymer has between 20% to 50% hydrophilicity.

### Claim 9 (depends on 1)

The catheter of claim 1, wherein the non-electrically conductive section comprises a non-hydrophilic polymer.

### Claim 10 (depends on 1)

The intravascular catheter of claim 1, wherein the first layer is inside the second layer.

### Claim 11 (depends on 1)

The intravascular catheter of claim 1, wherein the three or more sections that are permeable to RF radiation do not include the second layer.

### Claim 12 (depends on 1)

The intravascular catheter of claim 1, wherein the three or more sections that are permeable to RF radiation consist essentially of the first layer.

### Claim 13 (depends on 1)

The intravascular catheter of claim 1, wherein the electrode extends under three or more sections that are permeable to RF.

### Claim 14 (depends on 1)

The intravascular catheter of claim 1, wherein the electrode is helically shaped.

### Claim 15 (depends on 14)

The intravascular catheter of claim 14, wherein the elongate member extends the length of the balloon.

### Claim 16 (depends on 1)

The intravascular catheter of claim 1, wherein the elongate member comprises a guidewire lumen having an open distal end.

### Claim 17 (depends on 1)

The intravascular catheter of claim 1, wherein the elongate member further comprises a fluid supply lumen having an opening fluidly connected to the balloon lumen and a fluid return lumen having an opening fluidly connected to the shaft.

### Claim 18 (depends on 17)

The intravascular catheter of claim 17, wherein the fluid supply lumen opening is distal the three or more sections that are permeable to RF radiation.

### Claim 19 (depends on 17)

The intravascular catheter of claim 17, further comprising a fluid supply, wherein the first layer is more compliant than the second layer, wherein the three or more sections that are permeable to RF radiation are in the form of RF permeable windows, and wherein pressure provided by fluid from the fluid supply causes the RF permeable windows to bulge out.

### Claim 20 (depends on 1)

The intravascular catheter of claim 1, wherein the three or more sections that are permeable to RF radiation are in the form of RF permeable windows, and wherein the RF permeable windows are arranged so that any line drawn longitudinally along the balloon wall passes through at least one RF permeable window.