# US 11,998,284 B2 · Articulating guide with integral position sensor

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- Number: US 11,998,284 B2
- Document ID: US11998284B2
- Status: Granted
- Kind: B2
- Application number: 16/670,190
- Filed: 2019-10-31
- Published: 2020-06-11
- Granted: 2024-06-04
- Earliest claimed: 2018-12-07
- Assignees: Acclarent, Inc.
- Applicants: Acclarent, Inc.
- Inventors: Jetmir Palushi; Jonathan A. Syby; Itzhak Fang; Michelle Higley
- Web page: https://patentgrep.com/patent/US11998284B2

## CPC

- A61B 5/1076: {for measuring dimensions inside body cavities, e.g. using catheters (A61B3/1005 takes precedence)}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 1/00154: {using guiding arrangements for insertion}
- A61B 1/015: Control of fluid supply or evacuation
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61B 5/062: {using magnetic field}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/24: for use in the oral cavity, larynx, bronchial passages or nose (for medical inspection of cavities or tubes in the body A61B1/00); Tongue scrapers
- A61B 2017/00323: {Cables or rods}
- A61B 2017/0034: {adapted to be inserted through a working channel of an endoscope}
- A61B 2017/3445: {used as instrument channel for multiple instruments}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2072: {Reference field transducer attached to an instrument or patient}
- A61B 2090/067: {for measuring angles}
- A61B 2505/05: Surgical care
- A61B 2562/0223: Magnetic field sensors
- A61M 25/0127: {Magnetic means; Magnetic markers}
- A61M 25/09: Guide wires
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- 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

A guide sheath includes ports at a handle portion through which flexible endoscopic tools may be advanced until they emerge from corresponding ports at a distal tip of the guide sheath. The guide sheath includes a position sensor at its distal tip that is compatible with an image guided surgery (IGS) system, such that a virtual view of the distal tip's position relative to a surgical site may be presented by the IGS system. The virtual view may assist a surgeon in precisely positioning the distal tip at the surgical site, and then one or more flexible endoscopic tools may be advanced the length of the guide sheath for use at the surgical site. The guide sheath may also include an articulating portion at the distal tip that may be deflected in one or more directions in order to provide additional control over placement within the surgical site.

## Claims

### Claim 1

A guide sheath comprising:
(a) an origin port comprising a plurality of proximal channel openings;
(b) a destination port comprising a plurality of distal channel openings, the destination port being distal to the origin port;
(c) a shaft between the origin port and the destination port, the shaft comprising:
(i) a plurality of channels, each channel of the plurality of channels connecting one proximal channel opening of the plurality of proximal channel openings to one distal channel opening of the plurality of distal channel openings, the plurality of channels comprising:
(A) a tool channel, the tool channel being sized and configured to receive a tool,
(B) an endoscope channel, the endoscope channel being sized and configured to receive an endoscope,
(C) an illumination channel, the illumination channel being sized and configured to receive an illumination source, and
(D) a tool tracking sensor, the tool tracking sensor being configured to generate a signal indicating a distance to which a tool is advanced in the tool channel, and
(ii) an articulating portion at a distal end of the shaft, the articulating portion being configured to articulate, the destination port being distal to the articulating portion, and
(iii) a straight portion at a proximal end of the shaft, the straight portion being configured to remain straight during articulation of the articulating portion, the origin port being proximal to the straight portion;
(d) a first position sensor located at the destination port, the first position sensor being configured to cooperate with an image guided surgery (IGS) navigation system to determine a current position of the first position sensor;
(e) a second position sensor located proximal to the articulating portion and at the straight portion, the second position sensor being configured to operate with the IGS navigation system to determine a current position of the second position sensor;
(f) an integrated endoscope positioned within the endoscope channel, the endoscope channel being adapted to receive the integrated endoscope at the proximal channel opening of the endoscope channel and guide the integrated endoscope to the distal channel opening of the endoscope channel as the integrated endoscope is advanced into the endoscope channel;
(g) an integrated irrigation and suction tool positioned within the tool channel, the tool channel being adapted to receive the integrated irrigation and suction tool at the proximal channel opening of the tool channel and guide the integrated irrigation and suction tool to the distal channel opening of the tool channel as the integrated irrigation and suction tool is advanced into the tool channel; and
(h) an illumination source positioned within the illumination channel, the illumination channel being adapted to receive the integrated illumination source positioned at the proximal channel opening of the illumination channel and guide the integrated illumination source positioned to the distal channel opening of the illumination channel as the integrated illumination source positioned is advanced into the illumination channel;
at least one channel of the plurality of channels being configured to transfer fluid between the origin port and the destination port.

### Claim 2 (depends on 1)

The guide sheath of claim 1, the first position sensor being configured to generate an electrical signal in response to a magnetic field, the electrical signal generated by the first position sensor being configured to indicate the position of the first position sensor within the magnetic field.

### Claim 3 (depends on 1)

The guide sheath of claim 1, the origin port comprising a handle from which the shaft extends, the handle being adapted to be held in a hand during use.

### Claim 4 (depends on 1)

The guide sheath of claim 1, further comprising a control wire with a first end fixed at the distal end of the guide sheath and a second end proximal to the first end, such that the second end may be retracted to cause the articulating portion to flex in a first direction.

### Claim 5 (depends on 4)

The guide sheath of claim 4, a distance of displacement of the control wire within the guide sheath determining a degree to which the articulating portion flexes in the first direction.

### Claim 6 (depends on 4)

The guide sheath of claim 4, the control wire being coupled at the first end to an articulation control, the articulation control being configured to retract the second end of the control wire and thereby cause the flex.

### Claim 7 (depends on 1)

The guide sheath of claim 1, further comprising the IGS navigation system, the IGS navigation system being configured to display the current position of the destination port on a pre-operative image of a surgical site based on a signal from the first position sensor.

### Claim 8 (depends on 7)

The guide sheath of claim 7, the IGS navigation system being further configured to determine a current flex of the articulating portion by comparing a current position of the first position sensor to a current position of the second position sensor and display the articulating portion on the pre-operative image based on the current position and the current flex.

### Claim 9 (depends on 8)

The guide sheath of claim 8, the IGS navigation system being further configured to determine a position of a distal end of a deployed tool within a channel of the plurality of channels and display the position of the distal end of the deployed tool on the pre-operative image.

### Claim 10 (depends on 1)

The guide sheath of claim 1, the first position sensor being configured to be integrated along an exterior surface of the destination port.

### Claim 11 (depends on 1)

The guide sheath of claim 1, the first position sensor being configured to be integrated within an interior portion of the destination port.

### Claim 12 (depends on 1)

The guide sheath of claim 1, the first position sensor comprising a circumferential sensor positioned around a circumference of the destination port.

### Claim 13 (depends on 1)

The guide sheath of claim 1, the articulating portion of the shaft including a plurality of sections configured to articulate the articulating portion.

### Claim 14 (depends on 1)

The guide sheath of claim 1, further comprising a third position sensor, the first and third position sensors being offset from one another around a circumference of the destination port.

### Claim 15 (depends on 1)

The guide sheath of claim 1, the tool tracking sensor including a motion sensor.

### Claim 16 (depends on 1)

The guide sheath of claim 1, the tool tracking sensor including a proximity sensor.

### Claim 17 (depends on 1)

The guide sheath of claim 1, the tool tracking sensor including an optical sensor.

### Claim 18 (depends on 1)

The guide sheath of claim 1, the tool tracking sensor being positioned at the origin port.

### Claim 19 (depends on 1)

The guide sheath of claim 1, the tool tracking sensor being positioned at the destination port.

### Claim 20

An image guided surgery (IGS) navigation system comprising:
(a) a magnetic field generator operable to provide a magnetic field;
(b) a guide sheath comprising:
(i) a shaft defining a central longitudinal axis and a plurality of channels, the shaft including a straight portion at a proximal end of the shaft, the shaft further including an origin port, the origin port being proximal to the straight portion, the plurality of channels including:
(A) at least one working channel configured to slidably receive an instrument, the at least one working channel being open at a distal end of the shaft,
(B) an endoscope channel configured to receive an endoscope, the endoscope channel being laterally offset from the central longitudinal axis and from the at least one working channel, and
(C) an illumination channel configured to transmit light or receive a light source, the illumination channel being laterally offset from the central longitudinal axis and from the at least one working channel,
(ii) an articulating portion at the end of the shaft, the articulating portion having a distal end and a destination port, the articulating portion being configured to articulate, the destination port being distal to the articulating portion, the straight portion being configured to remain straight during articulation of the articulating portion,
(iii) a first position sensor located at or distal to the distal end of the articulating portion, the articulating portion being operable to change the position of the distal end of the articulating portion relative to the shaft,
(iv) a second position sensor located proximal to the articulating portion and at the straight portion, the second position sensor being configured to operate with the magnetic field generator to determine a current position of the second position sensor, and
(v) an instrument tracking sensor, the instrument tracking sensor being configured to generate a signal indicating a distance to which an instrument is advanced in the working channel;
(c) a display;
(d) a flexible instrument positioned within a working channel of the least one working channel of the guide sheath, with a distal end of the flexible instrument being extendable from the distal end of the articulating portion, the flexible instrument comprising an irrigation and suction tool, the working channel being adapted to receive the irrigation and suction tool at a proximal opening of the working channel and guide the irrigation and suction tool to a distal opening of the working channel as the irrigation and suction tool is advanced into the tool channel; and
(e) a processor configured to:
(i) determine a current position of the first position sensor and a current position of the second position sensor within the magnetic field,
(ii) display a first representation of the position of a distal end of the guide sheath on a preoperative image in real-time based on a signal generated by the first position sensor in response to the magnetic field,
(iii) determine a current articulation of the articulating portion that is based on the respective current positions of the first position sensor and the second position sensor,
(iv) determine a position of the distal and proximal ends of the flexible instrument based, in part, on the determined current articulation of the articulating portion and on a signal from the instrument tracking sensor indicating a distance to which the flexible instrument is advanced in the working channel, and
(v) display a second representation of the position of the distal end of the flexible instrument on the preoperative image in real-time.