# US 10,368,951 B2 · Robotic catheter system and methods

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- Number: US 10,368,951 B2
- Document ID: US10368951B2
- Status: Granted
- Kind: B2
- Application number: 15/283,793
- Filed: 2016-10-03
- Published: 2017-03-30
- Granted: 2019-08-06
- Earliest claimed: 2005-07-01
- Assignees: Auris Health, Inc.
- Applicants: Auris Health, Inc.
- Inventors: Frederic H. Moll; Daniel T. Wallace; Gregory J. Stahler; David F. Moore; Daniel T. Adams; Kenneth M. Martin; Robert G. Younge; Michael R. Zinn; Gunter D. Niemeyer; David Lundmark
- Web page: https://patentgrep.com/patent/US10368951B2

## CPC

- A61B 34/30: Surgical robots
- A61B 1/2676: {Bronchoscopes}
- A61B 1/273: for the upper alimentary canal, e.g. oesophagoscopes or gastroscopes
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 17/062: Needle manipulators
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 34/25: {User interfaces for surgical systems}
- A61B 34/37: Leader-follower robots (A61B34/35 takes precedence)
- A61B 34/71: {Manipulators operated by drive cable mechanisms}
- A61B 34/74: {Manipulators with manual electric input means}
- A61B 34/76: {Manipulators having means for providing feel, e.g. force or tactile feedback}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61B 1/018: for receiving instruments
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/7285: {for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal}
- A61B 6/541: {involving acquisition triggered by a physiological signal}
- A61B 8/0808: {for diagnosis of the brain}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 18/08: by means of electrically-heated probes
- A61B 46/10: specially adapted for instruments{, e.g. microscopes}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00238: {Type of minimally invasive operation (A61B2017/00805 takes precedence)}
- A61B 2017/00243: {cardiac}
- A61B 2017/00296: {mounted on an endoscope}
- A61B 2017/003: {Steerable}
- A61B 2017/00336: {with a protective sleeve, e.g. retractable or slidable}
- A61B 2017/00743: {Type of operation; Specification of treatment sites (A61B2017/00238 takes precedence)}
- A61B 2017/00805: {Treatment of female stress urinary incontinence}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound}
- A61B 2034/256: {having a database of accessory information, e.g. including context sensitive help or scientific articles}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2034/303: {specifically adapted for manipulations within body lumens, e.g. within lumen of gut, spine, or blood vessels}
- A61B 2034/715: {Cable tensioning mechanisms for removing slack}
- A61B 2090/035: {preventing further rotation}
- A61B 2090/062: {penetration depth}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/364: {Correlation of different images or relation of image positions in respect to the body}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3784: {both receiver and transmitter being in the instrument or receiver being also transmitter}
- A61M 25/0105: {Steering means as part of the catheter or advancing means; Markers for positioning (systems for detection of markers A61B)}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- B33Y 80/00: Products made by additive manufacturing
- 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)}
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING

## Abstract

The apparatus of one embodiment of the present invention is comprised of a flexible sheath instrument, a flexible guide instrument, and a tool. The flexible sheath instrument comprises a first instrument base removably coupleable to an instrument driver and defines a sheath instrument working lumen. The flexible guide instrument comprises a second instrument base removably coupleable to the instrument driver and is threaded through the sheath instrument working lumen. The guide instrument also defines a guide instrument working lumen. The tool is threaded through the guide instrument working lumen. For this embodiment of the apparatus, the sheath instrument and guide instrument are independently controllable relative to each other.

## Claims

### Claim 1

A robotic medical system, comprising:
an instrument driver comprising a motor and an instrument interface, the instrument interface comprising a drive element operatively coupled to the motor;
a steerable catheter comprising:
an elongate body defining a lumen,
a control element extending through the elongate body to a distal end portion of the steerable catheter, and
an instrument base operatively coupled to the instrument interface, the instrument base comprising a pulley operatively coupled to the control element and the drive element such that actuation of the drive element by the motor actuates the pulley causing actuation of the control element and the distal end portion;
a controller having control logic configured to operate the motor of the instrument driver; and
an ultrasound transducer integrated in the steerable catheter and configured to acquire data,
wherein the data acquired from the ultrasound transducer during movement through a patient is used by the controller, based on the control logic, to control the motor of the instrument driver to actuate the distal end portion of the steerable catheter to navigate the steerable catheter through the patient.

### Claim 2 (depends on 1)

The robotic medical system of claim 1, wherein the control element comprises one or more control elements.

### Claim 3 (depends on 2)

The robotic medical system of claim 2, wherein the pulley comprises one or more pulleys, and wherein each of the one or more pulleys is operatively coupled to a respective one of the one or more control elements.

### Claim 4 (depends on 3)

The robotic medical system of claim 3, wherein the motor comprises one or more motors and the drive element comprises one or more drive elements configured to selectively actuate the one or more pulleys to tension the one or more control elements and effectuate steering of the distal end portion.

### Claim 5 (depends on 1)

The robotic medical system of claim 1, wherein the steerable catheter comprises a coaxial catheter system comprising an inner member and an outer member.

### Claim 6 (depends on 5)

The robotic medical system of claim 5, wherein the outer member comprises a flexible sheath and the inner member comprises a flexible guide.

### Claim 7 (depends on 1)

The robotic medical system of claim 1, wherein the data gathered is time of flight for acquiring images.

### Claim 8 (depends on 1)

The robotic medical system of claim 1, further comprising at least one localization sensor in the steerable catheter.

### Claim 9 (depends on 8)

The robotic medical system of claim 8, wherein the localization sensor and the ultrasound transducer enable capture of ultrasound slice data and a position and orientation of the ultrasound transducer at each acquired slice.

### Claim 10 (depends on 8)

The robotic medical system of claim 8, wherein a three dimensional tissue structure model is producible from the data acquired from the ultrasound transducer and the localization sensor.

### Claim 11 (depends on 1)

The robotic medical system of claim 1, wherein actuating the distal end portion of the steerable catheter comprises bending the distal end portion in a commanded direction.

### Claim 12 (depends on 1)

The robotic medical system of claim 1, wherein the controller is further configured to actuate one or more drive motors configured to linearly translate the steerable catheter.

### Claim 13 (depends on 12)

The robotic medical system of claim 12, wherein the controller is configured to control both actuation of the distal end portion and linear translation of the steerable catheter to navigate the steerable catheter in a desired position or path within a patient.

### Claim 14 (depends on 13)

The robotic medical system of claim 13, wherein the desired position is a center line of a tissue cavity.

### Claim 15 (depends on 13)

The robotic medical system of claim 13, wherein the desired position is against a wall of a tissue cavity.

### Claim 16 (depends on 13)

The robotic medical system of claim 13, wherein the desired position or path is within a gastrointestinal tract.

### Claim 17 (depends on 13)

The robotic medical system of claim 13, wherein the desired position or path is within a bronchial tract.

### Claim 18 (depends on 13)

The robotic medical system of claim 13, further comprising an operator workstation that comprises a user input device, wherein the controller is configured to receive a user input command from the user input device.

### Claim 19 (depends on 18)

The robotic medical system of claim 18, wherein the system comprises an automated driving setting wherein a navigation path of the steerable catheter is based on the ultrasound data.

### Claim 20 (depends on 18)

The robotic medical system of claim 18, wherein the system comprises a semi-automated driving setting wherein a navigation path of the steerable catheter is determined based on the user input command and automatically updated based on the ultrasound data.