# US 6,296,634 B1 · Ophthalmological surgery technique with active patient data card

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- Number: US 6,296,634 B1
- Document ID: US6296634B1
- Status: Granted
- Kind: B1
- Application number: 07/666,840
- Filed: 1991-03-08
- Granted: 2001-10-02
- Earliest claimed: 1991-03-08
- Assignees: VISX, Incorporated
- Inventors: Alan R. McMillen; Terrance N. Clapham; Charles R. Munnerlyn
- Web page: https://patentgrep.com/patent/US6296634B1

## CPC

- A61F 9/008: using laser
- A61F 9/00804: {Refractive treatments}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61F 2009/00844: {Feedback systems}
- A61F 2009/00872: {Cornea}
- Y10S 283/90: Medical record
- Y10S 283/904: Credit card
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

An ophthalmological laser surgery system having a laser, associated elements for delivering an optical beam from the laser to a patient eye location, a control unit for controlling the operation of the system and a system input/output device, is enabled by a patient data card. The data card originally contains both patient background and system control information, which is transferred to the control unit via the input/output device. During system operation, newly generated information, such as laser beam power, is stored in the data card to provide an independent record of the surgical procedure actually performed. After one use, the data card is invalidated to prevent further use.

## Claims

### Claim 1

A method of controlling a laser surgery system used to ablate the cornea by selective irradiation, said method comprising the steps of providing a laser surgery system including a system control unit, and enabling the system control unit by means of a patient data card bearing predetermined enabling information; and permanently altering the patient data card after the step of enabling the system control unit wherein the step of altering invalidates the patient data card from subsequent use to enable the system control unit.

### Claim 2 (depends on 1)

The method of claim 1 wherein the system control unit requires program instructions to operate the laser surgery system; and wherein said step of enabling includes the step of supplying at least some of said program instructions from the patient data card to the system control unit.

### Claim 3 (depends on 1)

The method of claim 1 wherein the laser surgery system is provided with a unique identifier, and wherein said step of enabling the system includes the step of supplying a matching unique identifier from the patient data card to the system control unit.

### Claim 4 (depends on 3)

The method of claim 3 wherein said unique identifier comprises the identity of an approved surgeon.

### Claim 5 (depends on 1)

The method of claim 1 further including the step of recording on the data card at least one surgical parameter actually employed during a surgical procedure by the laser surgery system.

### Claim 6 (depends on 5)

The method of claim 5 wherein said surgical parameter comprises a characteristic of the laser beam actually employed during a surgical procedure.

### Claim 7 (depends on 1)

The method of claim 1 wherein said step of altering is performed after the operation performed with the laser surgery system is completed.

### Claim 8

A method of controlling a laser surgery system used to ablate the cornea by selective irradiation, said method comprising the steps of:
(a) providing a laser surgery system having a system control unit requiring the entry of predetermined enabling information from a data card bearing said predetermined enabling information;
(b) enabling the system control unit to permit a corneal ablation procedure in respinse to the entry of said predetermined enabling information; and
(c) rendering the data card inoperative to enable the system after the corneal ablation procedure has been performed by permanently altering the data card so that data on the data card is not a capable of enabling said system.

### Claim 9 (depends on 8)

The method of claim 8 wherein the system control unit requires program instructions to operate the laser surgery system; and wherein said step of enabling includes the step of supplying at least some of said program instructions from the patient data card to the system control unit.

### Claim 10 (depends on 8)

The method of claim 8 further including the step of altering the patient data card after the step of enabling the system control unit.

### Claim 11 (depends on 8)

The invention of claim 8 wherein step (b) includes the steps of presenting the data card to a card reader and reading the predetermined information from the data card into the system control unit.

### Claim 12 (depends on 8)

The invention of claim 8 wherein said step (b) includes the step of comparing an information carried by the data card relating to an authorized surgeon with the unique identifier in the system control unit.

### Claim 13 (depends on 8)

The method of claim 8 further including the step of recording on the data card at least one surgical parameter actually employed during a surgical procedure by the laser surgery system.

### Claim 14 (depends on 13)

The method of claim 13 wherein said surgical parameter comprises a characteristic of the laser beam actually employed during a surgical procedure.

### Claim 15

A method of controlling a laser surgery system used to ablate the cornea by selective irradiation to prevent use of the system by unauthorized personnel, said method comprising the steps of:
(a) providing a system control unit for controlling the operation of a specific laser surgery system;
(b) providing a unique identifier to the system control unit, said unique identifier specifying the identity of a surgeon authorized to operate said specific system;
(c) providing an independent data carrier containing predetermined information including the identity of a surgeon authorized to operate said specific system;
(d) comparing the unique identifier in the system control unit with the identity of the authorized surgeon specified by the predetermined information contained in the independent data carrier;
(e) enabling said specific system to permit a corneal ablation procedure if the step (d) of comparing indicates a match; and
(f) rendering the data card inoperative to enable the system after the corneal ablation procedure has been performed by permanently altering the data on the data card so that the data on the data card is not capable of enabling said system.

### Claim 16 (depends on 15)

The invention of claim 15 wherein said step (d) is preceded by the steps of presenting the data card to the card reader and reading the predetermined information from the data card into the system control unit.

### Claim 17

A method of controlling a laser surgery system used to ablated the cornea by selective irradiation, said method comprising the steps of:
(a) providing a laser surgery system having a system control unit requiring the entry of predetermined enabling information from a data card bearing said predetermined enabling information, wherein said predetermined enabling information includes a predetermined type of laser surgery, and issuing the data card from a manufacturer of the laser surgery system, wherein the issued data card is pre-coded by the manufacturer with at least a portion of the enabling information including the predetermined type of laser surgery;
(b) enabling the system control unit to perform a corneal ablation procedure in response to the entry of said predetermined enabling information; and
(c) preventing the system control unit from performing a corneal ablation procedure of a type of laser surgery that is different than said predetermined type.

### Claim 18 (depends on 17)

The method of claim 17 wherein said system control unit includes a card reader; and wherein step (b) of enabling includes the steps of presenting the data card to the card reader and reading the predetermined information from the data card into the system control unit.

### Claim 19 (depends on 17)

The method of claim 17 wherein said predetermined information includes the identity of a surgeon authorized to perform a corneal ablation procedure with the laser surgery system; wherein said system control unit includes a unique identifier for the authorized surgeon; and wherein said step (b) of enabling includes the step of comparing the information carried by the data card relating to the authorized surgeon with the unique identifier in the system control unit.

### Claim 20 (depends on 17)

The method of claim 17 wherein said predetermined type of laser surgery comprises myopic photorefractive keratectomy.

### Claim 21 (depends on 17)

The method of claim 17 wherein said predetermined type of laser surgery comprises hyperopic photorefractive keratectomy.

### Claim 22 (depends on 17)

The method of claim 17 wherein said predetermined type of laser surgery comprises astigmatic photorefractive keratectomy.

### Claim 23 (depends on 17)

The method of claim 17 wherein said predetermined enabling information further includes a predetermined amount of laser surgery, the method further comprising impeding the system control unit from performing a corneal ablation procedure of an amount of laser surgery that is greater than said predetermined amount.

### Claim 24 (depends on 23)

The method of claim 23 wherein the predetermined amount comprises a total length of time that the corneal surface of the eye is exposed to irradiation from the laser surgery system.

### Claim 25 (depends on 23)

The method of claim 23 wherein the predetermined amount comprises a total amount of energy that is applied to the corneal surface of the eye from the laser surgery system.

### Claim 26 (depends on 23)

The method of claim 23 wherein the predetermined amount comprises a total amount of power that is applied to the corneal surface of the eye from the laser surgery system.

### Claim 27 (depends on 8, 15)

The method of any of claims 8, 15, or 17 wherein data cards are issued so as to effect regulatory control of laser ablation procedures performed by the laser surgery system per a regulatory agency.