# US 11,432,961 B2 · Automated viscous fluid control in vitreoretinal surgery

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- Number: US 11,432,961 B2
- Document ID: US11432961B2
- Status: Granted
- Kind: B2
- Application number: 15/591,498
- Filed: 2017-05-10
- Published: 2017-11-23
- Granted: 2022-09-06
- Earliest claimed: 2016-05-17
- Assignees: Alcon Inc.
- Applicants: Novartis AG
- Inventors: Tammo Heeren; Andrew David Johnson
- Web page: https://patentgrep.com/patent/US11432961B2

## CPC

- A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)}
- A61B 3/16: for measuring intraocular pressure, e.g. tonometers
- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61F 9/00736: {Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments (A61F9/008 takes precedence)}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/16877: {Passive flow controllers; Devices for setting a flow rate (clamp-type valves A61M39/28)}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site}
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2210/0612: Eyes
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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

Ophthalmic surgical devices, systems, and methods for automatically controlling the injection or extraction of viscous fluids from a patient's eye are provided. A syringe pump connected with an actuation line and a powered syringe provides pressures for viscous fluid injection or extraction in a vitreous chamber of the eye. A sensor disposed adjacent to or inside the eye determines sensor data relating to an intraocular pressure (IOP). The controller receives the sensor data and regulates the injection or extraction of the viscous fluid in response to the detected IOP, such as by controlling the syringe pump. The controller may determine whether the IOP is above an upper threshold or below a lower threshold and may control the syringe pump to regulate the injection or extraction of viscous fluid to maintain the IOP between the upper and the lower thresholds.

## Claims

### Claim 1

An ophthalmic surgical system, comprising:
a first pump connected with a first actuation line, the first pump being configured to provide an injection pressure for viscous fluid injection in a vitreous chamber of an eye of a patient;
a second pump connected with a second actuation line, the second pump being configured to provide an extraction pressure for low viscosity fluid extraction in the vitreous chamber of the eye of the patient;
a controller;
a sensor disposed adjacent to a distal end of the second actuation line, the sensor configured to:
detect the intraocular pressure (IOP) of the eye;
generate sensor data based on the detected IOP; and
provide the sensor data to the controller;
a foot pedal system configured to receive user input for controlling injection of the viscous fluid in the eye; and
wherein the controller is configured to:
set an upper pressure threshold value;
receive the sensor data relating to the IOP of the eye;
receive the user input from the foot pedal system indicating a user request for more viscous fluid injection;
compare the IOP to the upper pressure threshold value;
determine that the IOP exceeds the upper pressure threshold value;
override the user request and not increase viscous fluid injection;
control the first pump to reduce or stop the injection pressure; and
simultaneously, with controlling the first pump to reduce or stop the injection pressure, control the second pump to regulate the IOP in the eye.

### Claim 2 (depends on 1)

The system of claim 1, wherein the viscous fluid comprises one or more of a silicone oil, a perfluoron solution, a stem cell solution, and an adhesive.

### Claim 3 (depends on 1)

The system of claim 1, wherein the sensor data relating to IOP further comprises flow rate data.

### Claim 4 (depends on 1)

The system of claim 1, wherein the low viscosity fluid is a gas.

### Claim 5 (depends on 1)

The system of claim 1, wherein controlling the second pump comprises using a proportional-integral-derivative (PID) control for the second pump.

### Claim 6

An ophthalmic surgical system, comprising:
an infusion line having a proximal end, a distal end, and an infusion passage extending therethrough, the distal end of the infusion line being configured to enter into a vitreous chamber of an eye of a patient;
an actuation line having a proximal end and a distal end;
a sensor disposed adjacent to the distal end of the infusion line, the sensor being configured to:
detect a pressure at a location adjacent to the eye of the patient;
generate sensor data based on the detected pressure; and
provide the sensor data to the controller; and
a console coupled to the proximal end of the infusion line and the proximal end of the actuation line, the console comprising:
a syringe pump configured to provide pressures for viscous fluid extraction in the vitreous chamber through the actuation line;
an infusion chamber in fluid communication with the infusion passage;
an infusion pump configured to provide low viscosity fluid infusion from the infusion chamber to the vitreous chamber through the infusion passage;
a foot pedal system configured to receive user input for controlling an extraction of the viscous fluid in the eye; and
a controller configured to:
set a lower pressure threshold value;
receive the sensor data relating to an intraocular pressure (IOP) of the eye, the sensor data being determined at the location adjacent to the eye;
receive the user input from the foot pedal system indicating a user request for more viscous fluid extraction;
compare the IOP to the lower pressure threshold value;
determine that the IOP is below the lower pressure threshold value;
override the user request and not increase viscous fluid extraction;
control the syringe pump to reduce or stop the extraction pressure; and
simultaneously, with controlling the syringe pump to reduce or stop the extraction pressure, control the infusion pump to regulate the IOP in the eye.

### Claim 7 (depends on 6)

The system of claim 6, wherein the viscous fluid comprises one or more of a silicone oil, a perfluoron solution, a stem cell solution, and an adhesive.

### Claim 8 (depends on 6)

The system of claim 6, wherein the sensor data relating to IOP further comprises flow rate data.

### Claim 9 (depends on 6)

The system of claim 6, wherein the low viscosity fluid is a gas.

### Claim 10 (depends on 6)

The system of claim 6, wherein controlling the infusion pump comprises using a proportional-integral-derivative (PID) control for the infusion pump.

### Claim 11

A method, comprising:
providing an injection pressure, through a first pump, for viscous fluid injection in a vitreous chamber of an eye of a patient;
providing an extraction pressure, through a second pump, for low viscosity fluid extraction in the vitreous chamber of the eye of the patient;
receiving sensor data from a sensor adjacent to or in the eye of the patient, wherein the sensor is configured to:
detect a pressure in the vitreous chamber of the patient;
generate sensor data based on the detected pressure; and
provide the sensor data to a controller;
monitoring an intraocular pressure (IOP) of the eye based on the sensor data;
receiving user input indicating a user request for more viscous fluid injection or a user request for more viscous fluid extraction;
comparing the IOP to an upper pressure threshold value;
determining that the user input indicates a user request for more viscous fluid injection and the IOP exceeds the upper pressure threshold value;
overriding the user request and not increase viscous fluid injection; and
controlling the first pump to reduce or stop injection pressure of the viscous fluid injection and simultaneously, with controlling the first pump to reduce or stop injection pressure of the viscous fluid injection, controlling the second pump to regulate the IOP in the eye.

### Claim 12 (depends on 11)

The method of claim 11, further comprising calculating the IOP based on sensor data, the sensor data including data related to pressure, flow rate, or both.

### Claim 13 (depends on 11)

The method of claim 11 wherein the low viscosity fluid is a gas.

### Claim 14 (depends on 11)

The method of claim 11, wherein controlling the second pump comprises using a proportional-integral-derivative (PID) control for the second pump.
