# US 12,178,753 B2 · Systems and methods for physical and electronic security of medical devices

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- Number: US 12,178,753 B2
- Document ID: US12178753B2
- Status: Granted
- Kind: B2
- Application number: 17/571,344
- Filed: 2022-01-07
- Published: 2022-09-29
- Granted: 2024-12-31
- Earliest claimed: 2021-03-24
- Assignees: Stroma Medical Corporation
- Applicants: Stroma Medical Corporation
- Inventors: Gregg Homer
- Web page: https://patentgrep.com/patent/US12178753B2

## CPC

- A61F 9/008: using laser
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- A61F 2009/00876: {Iris}
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system for altering the eye color of a patient with a color alteration procedure includes a laser system having a housing around at least one component of the laser system. The laser system also has a perimeter circuit configured to detect a breach of the housing based on the perimeter circuit being broken resulting in an electrical current flowing through the perimeter circuit being ceased or a change in resistance in the perimeter circuit. The system also includes software that detects, by the perimeter circuit, the breach based on the perimeter circuit being broken. The software also executes, based on the breach, an electronic lockout of the laser system such that the laser system cannot be operated without receipt of a command lifting the electronic lockout.

## Claims

### Claim 1

A laser system for altering an eye color of a patient with a color alteration procedure, the laser system comprising:
a laser head comprising components to generate laser light at varying wavelengths;
a sensor;
at least one programmable processor; and
a non-transitory machine-readable medium storing instructions which, when executed by the at least one programmable processor, cause the at least one programmable processor to perform operations comprising:
detecting, utilizing the sensor, a condition that causes the laser system to initiate an electronic lockout;
executing, based on the condition, the electronic lockout of the laser system, wherein during the electronic lockout the laser system does not generate the laser light, and wherein executing the electronic lockout of the laser system comprises deleting a configuration file necessary for operation of the laser system;
receiving a command lifting the electronic lockout; and
in response to receiving the command lifting the electronic lockout, delivering the laser light to an eye of the patient to perform the color alteration procedure.

### Claim 2 (depends on 1)

The laser system of claim 1, the operations further comprising electronically notifying a third party in response to detecting the condition.

### Claim 3 (depends on 1)

The laser system of claim 1, wherein the condition is movement of the laser system, the operations further comprising determining the movement, and the electronic lockout is executed based on the movement.

### Claim 4 (depends on 1)

The laser system of claim 1, wherein the sensor is configured to detect movement comprising lateral movement, vertical movement, or tilting.

### Claim 5 (depends on 1)

The laser system of claim 1, wherein the sensor is configured to detect movement comprising vibrations.

### Claim 6 (depends on 1)

The laser system of claim 1, wherein the sensor comprises a gyroscope or mercury switch.

### Claim 7 (depends on 1)

The laser system of claim 1, wherein the condition is a location of the laser system, the operations further comprising determining the location, and the electronic lockout is executed based on the location.

### Claim 8 (depends on 7)

The laser system of claim 7, wherein the sensor comprises a GPS receiver, the operations further comprising:
determining the location based on GPS signals received at the GPS receiver; and
executing the electronic lockout when the location of the laser system is outside a permitted area.

### Claim 9 (depends on 8)

The laser system of claim 8, the operations further comprising:
receiving medical record information specifying a desired change in the eye color of the patient; and
extracting, from a database, treatment parameters for changing the eye color with the laser system, wherein the treatment parameters are based on the medical record information and the location of the laser system.

### Claim 10 (depends on 1)

The laser system of claim 1, further comprising:
a Pockels cell, wherein executing the electronic lockout of the laser system comprises disabling the laser system by controlling the Pockels cell of the laser system to stop or reduce laser power output by the laser system.

### Claim 11 (depends on 10)

The laser system of claim 10, wherein controlling the Pockels cell of the laser system to stop or reduce the laser power output by the laser system comprises reducing a voltage applied to a crystal in the Pockels cell.

### Claim 12 (depends on 1)

The laser system of claim 1, further comprising:
a galvos, wherein the configuration file comprises data describing movements of the galvos when executing a scanning pattern on the eye of the patient.

### Claim 13 (depends on 1)

The laser system of claim 1, wherein the sensor comprises a perimeter circuit.

### Claim 14 (depends on 13)

The laser system of claim 13, wherein the perimeter circuit is completed by one or more of a metallic screw, electrical contacts, a breakable conductive wire.

### Claim 15 (depends on 13)

The laser system of claim 13, further comprising a battery operatively connected to the perimeter circuit to energize the perimeter circuit, the operations further comprising executing the electronic lockout when energy remaining in the battery is below a battery lockout threshold.

### Claim 16 (depends on 15)

The laser system of claim 15, wherein the perimeter circuit is configured to be energized by main power to the laser system and the battery is operatively connected to the perimeter circuit such that when main power is interrupted the battery energizes the perimeter circuit.

### Claim 17 (depends on 1)

The laser system of claim 1, wherein executing the electronic lockout comprises locking out a control system of the laser system to prevent at least one command being accepted that is required for operation of the laser system.

### Claim 18 (depends on 1)

The laser system of claim 1, wherein the sensor comprises an image sensor, the operations further comprise:
capturing a first scan with the image sensor at a first time prior to the altering of the eye color, the first scan being of at least one of an iris or retina of the patient;
capturing a second scan with the image sensor at a second time later than the first time and prior to altering of the eye color, the second scan being at least one of the iris or the retina of the patient;
comparing the first scan captured at the first time with the second scan captured at the second time;
determining an identity of the patient based on matching the first scan captured at the first time with the second scan captured at the second time;
generating for display, on a user interface, a confirmation of the identity of the patient; and
enabling delivery of laser light by the laser system to the iris or retina of the patient upon confirmation of the identity.

### Claim 19 (depends on 18)

The laser system of claim 18, wherein the operations further comprise:
retrieving, from a database and based on the second scan, patient medical record data associated with the color alteration procedure; and
displaying the patient medical record data.

### Claim 20 (depends on 19)

The laser system of claim 19, wherein the operations further comprise automatically setting a laser power of the laser system based on the patient medical record data and a patient treatment plan.

### Claim 21 (depends on 20)

The laser system of claim 20, wherein setting the laser power comprises:
determining a beam spot size, a pulse duration, or a wavelength, the setting being determined based on the beam spot size, the pulse duration, or the wavelength.

### Claim 22 (depends on 20)

The laser system of claim 20, wherein setting the laser power comprises:
selecting a laser pulse width in a range from 1 nanosecond to 1 microsecond.

### Claim 23 (depends on 20)

The laser system of claim 20, wherein setting the laser power comprises:
selecting a laser pulse width that is below 1 nanosecond.