# US 11,896,779 B2 · MRI compatible ablation catheter system incorporating directional high-intensity ultrasound for treatment

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- Number: US 11,896,779 B2
- Document ID: US11896779B2
- Status: Granted
- Kind: B2
- Application number: 17/084,050
- Filed: 2020-10-29
- Published: 2021-06-17
- Granted: 2024-02-13
- Earliest claimed: 2012-08-15
- Assignees: Acoustic Medsystems, Inc.
- Applicants: Acoustic Medsystems, Inc.
- Inventors: Everette C. Burdette; Bruce M. Komadina; Emery M. Williams
- Web page: https://patentgrep.com/patent/US11896779B2

## CPC

- A61M 25/0127: {Magnetic means; Magnetic markers}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 29/18: Materials at least partially X-ray or laser opaque
- A61M 25/0082: {Catheter tip comprising a tool}
- A61N 7/022: {intracavitary}
- G01R 33/287: {involving active visualization of interventional instruments, e.g. using active tracking RF coils or coils for intentionally creating magnetic field inhomogeneities}
- G01R 33/4814: {MR combined with ultrasound}
- A61B 8/429: {characterised by determining or monitoring the contact between the transducer and the tissue}
- A61B 2017/00323: {Cables or rods}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00351: {Heart}
- A61B 2018/00547: {Prostate}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/374: {NMR or MRI}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12)

## Abstract

A magnetic resonance compatible catheter. The catheter incorporates directional high intensity ultrasound. The catheter may include imaging coils visible through magnetic resonance imaging. The location and placement of the catheter may be controlled by steering wires within lumen in the catheter guided by the location information from the magnetic resonance imaging.

## Claims

### Claim 1

A catheter device for treating tissue with ultrasound comprising:
an inner catheter comprising:
an ultrasonic transducer mounted on a rigid platform disposed within the inner catheter at a distal end of the catheter device defining a catheter device tip; and
a first radiofrequency (RF) tracking coil integrated within the inner catheter; and
a first plurality of lumens; and
an outer catheter around the inner catheter, the outer catheter concentric with the inner catheter and comprising:
at least two guide wires disposed within the outer catheter;
a second RF tracking coil integrated within the outer catheter provided at a location proximal the ultrasonic transducer relative to the first RF tracking coil; and
a second plurality of lumens.

### Claim 2 (depends on 1)

The catheter device of claim 1, wherein a first inner lumen of the first plurality of lumens comprises a power supply and a second inner lumen of the first plurality of lumens comprises a cooling system for the ultrasonic transducer at the catheter device tip.

### Claim 3 (depends on 1)

The catheter device of claim 1, wherein the inner catheter and the outer catheter have a bend radius of no more than about 2 cm.

### Claim 4 (depends on 1)

The catheter device of claim 1, wherein the at least two guide wires are placed in opposing outer lumens of the plurality of lumens.

### Claim 5 (depends on 4)

The catheter device of claim 4, wherein the at least two guide wires comprises nitinol.

### Claim 6 (depends on 1)

The catheter device of claim 1, wherein the inner catheter further comprises a third RF tracking coil proximal the ultrasonic transducer relative to the first RF tracking coil.

### Claim 7 (depends on 1)

The catheter device of claim 1, further comprising a plurality of ultrasonic transducers controllable to emit ultrasonic energy in a select pattern.

### Claim 8 (depends on 1)

The catheter device of claim 1, wherein the inner catheter comprises polyether ether ketone.

### Claim 9 (depends on 1)

A system for magnetic resonance imaging compatible ablative treatment of a target site, comprising:
the catheter device of claim 1;
a magnetic resonance imaging (MRI) system capable of detecting the RF tracking coils; and
a 3-dimensional modeling and guidance system having a 3-dimensional model of the target site and in communication with the MRI system to provide an indication of a position of the catheter device with respect to the target site.

### Claim 10 (depends on 1)

The catheter device of claim 1, wherein the catheter device tip has a different durometer than a proximal end of the catheter device.

### Claim 11 (depends on 1)

The catheter device of claim 1, wherein a durometer of the catheter device ranges from 70D to 35D.

### Claim 12 (depends on 1)

The catheter device of claim 1, wherein the rigid platform comprises ceramic.

### Claim 13 (depends on 1)

The catheter device of claim 1, further comprising a plurality of magnetic resonance (MR) contrast markers integrated into the inner catheter at two or more locations along the inner catheter.

### Claim 14 (depends on 1)

The catheter device of claim 1, wherein the ultrasonic transducer comprises one of a flat transducer assembly or a curvilinear transducer assembly.

### Claim 15 (depends on 1)

The catheter device of claim 1, wherein the catheter device has an outside diameter of less than 0.1″.

### Claim 16

A method for ablating myocardium to treat cardiac rhythm conditions comprising:
positioning, in proximity to myocardium, via transarterial, endovenous, transseptal atrial, or transaortic endoventricular access, a catheter device, the catheter device comprising:
an inner catheter comprising:
an ultrasonic transducer mounted on a rigid platform disposed within the inner catheter at a distal end of the catheter device defining a catheter device tip;
a first radiofrequency (RF) tracking coil integrated within the inner catheter; and
a first plurality of lumens; and
an outer catheter surrounding the inner catheter, the outer catheter concentric with the inner catheter and comprising:
at least two guide wires;
a second RF tracking coil integrated within the outer catheter provided at a location proximal the ultrasonic transducer relative to the first RF tracking coil; and
a second plurality of lumens;
determining a position and an orientation of the catheter device, using the RF tracking coils, the RF tracking coils providing a real time localized signal;
guiding the catheter device, using the at least two guide wires, based upon the position and the orientation of the catheter device, to a portion of a ventricular wall defining a treatment zone of the myocardium; and
rotating and directing the catheter device tip to point the ultrasonic transducer at the treatment zone, transmitting high-intensity ultrasound energy to selectively target and ablate the treatment zone under magnetic resonance (MR) guidance.

### Claim 17 (depends on 16)

The method of claim 16, wherein the position of the catheter device is determined in real time through at least one of:
pulse sequence application;
incorporation of multi-slice imaging, and
MR temperature monitoring.

### Claim 18 (depends on 9)

The method of claim 9, wherein a depth of the treatment zone is about 0-20 mm.

### Claim 19 (depends on 16)

The method of claim 16, wherein the ultrasonic transducer operates at a frequency of about 7-12 MHz at an intensity level of 10-15 W/cm2.