# US 2021/0330309 A1 · Case-specific fluid management

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- Number: US 2021/0330309 A1
- Document ID: US20210330309A1
- Status: Published application
- Kind: A1
- Application number: 17/235,619
- Filed: 2021-04-20
- Published: 2021-10-28
- Earliest claimed: 2020-04-27
- Assignees: Auris Health, Inc.
- Applicants: Auris Health, Inc.
- Inventors: Polly Charlene MA; Alexander J. TEAGUE; Toni DIVIC; Sarah PLEWE; Mouslim M. TATARKHANOV
- Web page: https://patentgrep.com/patent/US20210330309A1

## CPC

- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 34/35: for telesurgery
- A61B 34/30: Surgical robots
- A61B 34/74: {Manipulators with manual electric input means}
- A61M 1/77: {Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463)}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61M 3/0202: {with electronic control means or interfaces}
- A61M 3/0208: {before use}
- A61M 3/0216: {Pressure}
- A61M 3/022: {Volume; Flow rate}
- A61M 3/0241: {the liquid being supplied by gravity}
- A61M 3/0283: {with at least two inner passageways, a first one for irrigating and a second for evacuating (suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92)}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61B 2560/0487: Special user inputs or interfaces
- A61B 2562/0247: Pressure sensors
- A61M 1/732: {Visual indicating means for vacuum pressure}
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2209/084: Supporting bases, stands for equipment
- A61M 2210/1082: Kidney
- 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 method of managing fluid conditions in a patient involves advancing at least one medical instrument into a target organ of a patient, the at least one medical instrument comprising an irrigation channel and an aspiration channel, coupling the at least one medical instrument to an irrigation fluid source, providing irrigation from the irrigation fluid source into the target organ through the irrigation channel of the at least one medical instrument, determining an irrigation pressure limit based at least in part on one or more case-specific parameters, providing irrigation into the target organ through the irrigation channel, and limiting the irrigation based at least in part on the determined irrigation pressure limit.

## Claims

### Claim 1

A method of fluid management, the method comprising:
causing fluidics to be provided between a fluidics source and a kidney of a patient through a fluidics channel of at least one medical instrument disposed at least partially within the kidney;
determining a fluid pressure limit based at least in part on one or more case-specific parameters; and
limiting the fluidics based at least in part on the determined fluid pressure limit.

### Claim 2 (depends on 1)

The method of claim 1, wherein the one or more case-specific parameters comprise one or more of the following parameters:
angle of a sheath associated with the at least one medical instrument;
amount of aspiration flow;
whether active suction is implemented;
relative height of the sheath relative to the fluidics source; and
patient position.

### Claim 3 (depends on 2)

The method of claim 2, wherein the amount of aspiration flow is based on a number of passive fluid outflow channels from the kidney through the at least one medical instrument.

### Claim 4 (depends on 2)

The method of claim 2, wherein the sheath is a percutaneous-access sheath.

### Claim 5 (depends on 2)

The method of claim 2, further comprising determining the angle of the sheath based at least in part on a configuration of a robotic arm holding a catheter disposed at least partially within the at least one medical instrument.

### Claim 6 (depends on 2)

The method of claim 2, wherein the patient position is one of the group consisting of: prone, supine, modified-supine, and Trendelenburg.

### Claim 7 (depends on 1)

The method of claim 1, wherein said limiting the fluidics based at least in part on the determined fluid pressure limit maintains internal fluid pressure of the kidney below 33 mmHg.

### Claim 8 (depends on 1)

The method of claim 1, wherein said fluidics provision and limiting of the fluidics distend the kidney without causing damage to the kidney from over pressurization.

### Claim 9 (depends on 1)

The method of claim 1, wherein the fluid pressure limit is 150 mmHg.

### Claim 10 (depends on 1)

The method of claim 1, wherein said causing fluidics to be provided involves driving a pump of a fluid control system configured to control a rate of fluid flow from the fluidics source in accordance with the fluid pressure limit.

### Claim 11 (depends on 1)

The method of claim 1, further comprising determining a presence of a ureteral access sheath at least partially within the kidney, wherein the fluid pressure limit is based at least in part on said determination of the presence of the ureteral access sheath.

### Claim 12 (depends on 1)

The method of claim 1, wherein the fluidics channel is formed between concentric inner and outer sheaths of the at least one medical instrument.

### Claim 13 (depends on 1)

The method of claim 1, wherein the at least one medical instrument includes an aspiration channel formed between an inner sheath of the at least one medical instrument and a catheter disposed within the inner sheath.

### Claim 14 (depends on 1)

The method of claim 1, further comprising notifying a user of the fluid pressure limit using a user interface.

### Claim 15 (depends on 1)

The method of claim 1, further comprising:
determining the one or more case-specific parameters continuously during an operative period; and
updating the fluid pressure limit in real-time based on the continuously-determined one or more case-specific parameters.

### Claim 16

A surgical system comprising:
a medical instrument assembly including an irrigation channel;
a robotic subsystem including one or more articulating arms configured to hold one or more components of the medical instrument assembly;
an irrigation source fluidly coupled to the medical instrument assembly;
an irrigation control subsystem configured to control a flow of fluid from the irrigation source to the medical instrument assembly; and
control circuitry associated with the irrigation control subsystem, the control circuitry being configured to:
determine an irrigation pressure limit based at least in part on one or more case-specific parameters; and
control the flow of fluid from the irrigation source to the medical instrument assembly in accordance with the irrigation pressure limit.

### Claim 17 (depends on 16)

The system of claim 16, wherein the one or more case-specific parameters comprise one or more of the following parameters:
angle of a sheath associated with the medical instrument assembly;
amount of aspiration flow;
whether active suction is implemented;
relative height of the sheath relative to the irrigation source; and
patient position.

### Claim 18 (depends on 16)

The system of claim 16, wherein:
the irrigation channel is formed between inner and outer sheaths of a percutaneous-access instrument of the medical instrument assembly; and
the one or more components comprises a catheter configured to be disposed at least partially within the inner sheath of the percutaneous-access instrument.

### Claim 19 (depends on 16)

The system of claim 16, wherein:
the control circuitry is further configured to determine an angle of a distal portion of one of the one or more articulating arms; and
one of the one or more case-specific parameters is based on the angle.

### Claim 20 (depends on 16)

The system of claim 16, wherein:
the medical instrument assembly includes an active suction lumen; and
the one or more case-specific parameters indicate a status of the active suction lumen.

### Claim 21 (depends on 16)

The system of claim 16, further comprising an electronic display, wherein the control circuitry is further configured to present, using the electronic display, a graphical user interface indicating a pressure range having an upper limit at the irrigation pressure limit.

### Claim 22 (depends on 16)

The system of claim 16, wherein the control circuitry is further configured to:
determine the one or more case-specific parameters continuously during an operative period; and
update the irrigation pressure limit continuously during the operative period based at least in part on the continuously-determined one or more case-specific parameters.

### Claim 23 (depends on 16)

The system of claim 16, wherein:
the irrigation source comprises a bag of fluid coupled to a support structure; and
the one or more case-specific parameters indicate a height of at least one of the bag of fluid and a portion of the support structure relative to a height of one or more components of the medical instrument assembly.

### Claim 24 (depends on 16)

The system of claim 16, wherein:
the medical instrument assembly includes one or more pressure sensors configured to be disposed in a target organ of a patient; and
the one or more case-specific parameters indicate a pressure of the target organ based at least in part on a signal from the one or more pressure sensors.

### Claim 25

A method of fluid management, the method comprising:
receiving case-specific parameter data relating to fluid pressure in a target organ of a patient;
determining a case-specific irrigation pressure limit based at least in part on the case-specific parameter data;
generating user interface data representing a user interface indicating the case-specific irrigation pressure limit; and
transmitting the user interface data to an electronic display to thereby cause the user interface to be displayed to a user.

### Claim 26 (depends on 25)

The method of claim 25, wherein the user interface data further represents an active suction level applied to the target organ.

### Claim 27 (depends on 25)

The method of claim 25, further comprising:
determining that an irrigation pressure associated with the target organ exceeds a predetermined threshold; and
generating additional user interface data representing a limit-overwrite interface querying the user as to whether the user wishes to overwrite the case-specific irrigation pressure limit.

### Claim 28 (depends on 25)

The method of claim 25, wherein the case-specific parameter data is manually-input parameter data.
