# US 11,439,298 B2 · Surface mapping and visualizing ablation system

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- Number: US 11,439,298 B2
- Document ID: US11439298B2
- Status: Granted
- Kind: B2
- Application number: 16/432,243
- Filed: 2019-06-05
- Published: 2019-10-10
- Granted: 2022-09-13
- Earliest claimed: 2013-04-08
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: John P. Claude; Amr Salahieh; Tom Saul; Jonah Lepak; Adnan Merchant
- Web page: https://patentgrep.com/patent/US11439298B2

## CPC

- A61B 1/3137: {for examination of the interior of blood vessels}
- A61B 1/00045: {Display arrangement}
- A61B 1/00082: {Balloons}
- A61B 1/00087: {Tools (A61B17/00234 takes precedence)}
- A61B 1/00096: {Optical elements}
- A61B 1/05: characterised by the image sensor, e.g. camera, being in the distal end portion
- A61B 1/051: {Details of CCD assembly}
- A61B 1/0676: {at distal tip of an endoscope}
- A61B 1/313: for introducing through surgical openings, e.g. laparoscopes
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/0538: invasively, e.g. using a catheter
- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- 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})
- A61M 25/1011: {Multiple balloon catheters}
- A61B 5/6853: {with a balloon}
- A61B 5/6855: {with a distal curved tip}
- A61B 18/1206: {Generators therefor}
- A61B 18/1815: {using microwaves}
- A61B 90/30: Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2017/00831: {Material properties}
- A61B 2017/22038: {with a guide wire}
- A61B 2018/00011: {with fluids}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00029: {open}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/0022: {Balloons}
- A61B 2018/00232: {having an irregular shape}
- A61B 2018/00238: {porous}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00285: {Balloons}
- A61B 2018/00291: {using suction}
- A61B 2018/00351: {Heart}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00375: {Ostium, e.g. ostium of pulmonary vein or artery}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00744: {Fluid flow}
- A61B 2018/00791: {Temperature}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00815: {measured by a thermistor}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00898: {Alarms or notifications created in response to an abnormal condition}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/124: {switching the output to different electrodes, e.g. sequentially}
- A61B 2018/1435: {Spiral}
- A61B 2018/1465: {Deformable electrodes}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/2048: {using an accelerometer or inertia sensor}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2034/2057: {Details of tracking cameras}
- A61B 2034/2065: {Tracking using image or pattern recognition}
- A61B 2090/0454: {by reflection}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/309: {using white LEDs}
- A61B 2090/3614: {using optical fibre}
- A61B 2090/364: {Correlation of different images or relation of image positions in respect to the body}
- A61B 2090/367: {creating a 3D dataset from 2D images using position information}
- A61B 2090/371: {with simultaneous use of two cameras}
- A61B 2090/373: {using light, e.g. by using optical scanners}
- A61B 2090/395: {with marking agent for marking skin or other tissue}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2217/007: with irrigation system
- A61B 2218/002: Irrigation
- A61B 2562/125: characterised by the manufacture of electrodes
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/0133: {Tip steering devices}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2025/1047: {having centering means, e.g. balloons having an appropriate shape}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- C08L 2201/12: Shape memory
- 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)}
- 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)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

Visualization and ablation systems and catheters. The systems can capture a plurality of different 2D images of the patient's anatomy adjacent an expandable member, each of which visualizes at least one part of the patient that is in contact with the expandable membrane, tag each of the plurality of different 2D images with information indicative of the position and orientation of a locational element when each of the plurality of different 2D images was captured, create a patient map, wherein creating the patient map comprises placing each of the plurality of different 2D images at the corresponding tagged position and orientation into a 3D space, and display the patient map.

## Claims

### Claim 1

A visualization system comprising:
an ablation catheter including:
an expandable membrane,
a camera disposed within the expandable membrane, the camera having a field of view, the camera orientated such that the camera field of view includes the expandable membrane when the expandable membrane is expanded, and
a magnetic sensor with a fixed position and orientation relative to the camera, wherein the magnetic sensor is adapted such that the position and orientation of the magnetic sensor can be defined in a global frame of reference;
a computer configured to:
access a plurality of different 2D images captured by the camera of a patient's anatomy adjacent the expandable member, each of which visualizes at least one part of the patient's anatomy that is in contact with the expandable membrane,
tag each 2D image of the plurality of different 2D images with information indicative of the position and orientation of the magnetic sensor when each 2D image of the plurality of different 2D images was captured, and
create a patient map by placing each 2D image of the plurality of different 2D images at a corresponding tagged position and orientation into a 3D space; and
a display configured to present the created patient map.

### Claim 2 (depends on 1)

The visualization system of claim 1, wherein the ablation catheter includes a plurality of cameras disposed within the expandable membrane, each camera of the plurality of cameras having a different field of view, the magnetic sensor having a fixed position and orientation relative to each camera of the cameras.

### Claim 3 (depends on 1)

The visualization system of claim 1, wherein the magnetic sensor is positioned within the expandable membrane.

### Claim 4 (depends on 1)

The visualization system of claim 1, wherein the ablation catheter includes a shaft extending through the expandable membrane and including a guidewire lumen, wherein the magnetic sensor is secured to the shaft.

### Claim 5 (depends on 1)

The visualization system of claim 1, wherein the ablation catheter includes an elongate member, wherein the magnetic sensor is secured to an outer surface of the elongate member.

### Claim 6 (depends on 1)

The visualization system of claim 1, wherein the magnetic sensor includes a coil.

### Claim 7 (depends on 1)

The visualization system of claim 1, wherein the magnetic sensor includes a plurality of orthogonal coils.

### Claim 8 (depends on 1)

The visualization system of claim 1, wherein the magnetic sensor includes a magneto-restrictive sensor.

### Claim 9 (depends on 1)

The visualization system of claim 1, wherein the computer is further configured to create the patient map by at least projecting the plurality of different 2D images onto a 2D plane.

### Claim 10 (depends on 9)

The visualization system of claim 9, wherein the camera has a reference frame in a fixed position and orientation relative to the magnetic sensor, wherein the computer is further configured to tag each 2D image of the plurality of different 2D images with information indicative of the position and orientation of the magnetic sensor when each 2D image of the plurality of different 2D images was captured by at least determining a position vector in the camera field of view in the global frame of reference.

### Claim 11 (depends on 10)

The visualization system of claim 10, wherein determining the position vector comprises using a known distance between the camera and a first scaling element carried by the expandable membrane.

### Claim 12 (depends on 10)

The visualization system of claim 10, wherein determining the position vector comprises estimating by calculating a distance between the camera and a point on the patient's anatomy.

### Claim 13 (depends on 12)

The visualization system of claim 12, wherein estimating by calculating a distance between the camera and a point on the patient's anatomy uses a change in a known dimension of a marker carried by the expandable member within the image.

### Claim 14 (depends on 1)

The visualization system of claim 1, wherein the computer is further configured to create the patient map by at least mapping at least one natural landmark into the patient map.

### Claim 15 (depends on 1)

The visualization system of claim 1, wherein the computer is further configured to create the patient map by at least mapping at least one electrical landmark into the patient map, the at least one electrical landmark selected from a group consisting of: an electrophysiological landmark, a rotor, a nerve cell cluster, a nerve disposed on an inner wall of a heart of the patient, and a nerve extending adjacent the heart.

### Claim 16 (depends on 1)

The visualization system of claim 1, wherein the computer is further configured to create the patient map by at least mapping at least one created landmark into the patient map, the at least one created landmark including a zone indicative of where the expandable membrane has made contact with tissue or has not made contact with tissue.

### Claim 17 (depends on 16)

The visualization system of claim 16, wherein the mapping includes distinguishing a color in the plurality of different 2D images that indicates that contact with tissue has been made from a color in the plurality of different 2D images that indicates that contact with tissue has not been made.

### Claim 18 (depends on 16)

The visualization system of claim 16, wherein the at least one created landmark includes a region of tissue into which ablation energy has been delivered.

### Claim 19 (depends on 1)

The visualization system of claim 1, further comprising:
an electromagnetic tracking system including a field generator and configured to determine the position and orientation of the magnetic sensor within the global frame of reference.