# US 9,262,252 B2 · Integration of control software with a medical device and system

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,262,252 B2
- Document ID: US9262252B2
- Status: Granted
- Kind: B2
- Application number: 14/050,570
- Filed: 2013-10-10
- Published: 2014-03-27
- Granted: 2016-02-16
- Earliest claimed: 2007-12-27
- Assignees: St. Jude Medical, Atrail Fibrillation Division, Inc.
- Applicants: St. Jude Medical, Atrial Fibrillation Division, Inc.
- Inventors: Bruce E. Kirkpatrick; Timothy E. Ciciarelli
- Web page: https://patentgrep.com/patent/US9262252B2

## CPC

- G05B 19/042: using digital processors (G05B19/05 takes precedence)
- A61B 18/1206: {Generators therefor}
- G06F 11/0778: {Dumping, i.e. gathering error/state information after a fault for later diagnosis}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/00482: {with a code}
- A61B 2017/320069: {for ablating tissue}
- A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter}
- A61B 2034/256: {having a database of accessory information, e.g. including context sensitive help or scientific articles}
- A61N 7/02: Localised ultrasound hyperthermia
- A61N 7/022: {intracavitary}
- A61N 2007/0052: {using the same transducer for therapy and imaging}
- G05B 2219/23278: Program by data flow
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A medical device for diagnosis or treatment of tissue is disclosed. The device includes an electronically-controlled tool configured for diagnosis or treatment, an electrical connector, and a computer readable memory. The electrical connector is configured for connection with an electronic control unit and configured to receive control signals, including signals concerning the operation of the tool, from the electronic control unit. The computer readable memory is accessible through the connector. The memory can include a set of programming instructions for control of the tool, and the programming instructions can be configured to be downloadable from the memory upon connection of the electrical connector with the electronic control unit. A system is also disclosed in which the electronic control unit is configured to transmit a data log from memory in the electronic control unit to the memory in the medical device upon the occurrence or detection of a predetermined event.

## Claims

### Claim 1

A method for providing a data log in a medical system including a detachable medical device, the method comprising:
providing a medical system including an electronic control unit having a computer readable memory and a detachable medical device having a computer readable memory including a first set of programming instructions, wherein the first set of programming instructions comprises instructions for operating the detachable medical device;
connecting the detachable medical device to the electronic control unit;
writing the instructions for operating the detachable medical device to the computer readable memory of the electronic control unit;
initiating a therapy or procedure associated with the medical system according to the instructions for operating the detachable medical device;
detecting the occurrence of a fault or event in the detachable medical device during the therapy or procedure;
transmitting a data log from the memory of the electronic control unit to the memory of the detachable medical device upon detecting the fault or event; and
disconnecting the detachable medical device from the electronic control unit.

### Claim 2 (depends on 1)

The method of claim 1, further comprising installing a second set of programming instructions in the memory of the detachable medical device after disconnecting the detachable medical device from the electronic control unit.

### Claim 3 (depends on 2)

The method of claim 2, further comprising connecting the detachable medical device to the electronic control unit and, following the connection of the detachable medical device to the electronic control unit, using the second set of programming instructions to overwrite at least a portion of programming instructions resident in the memory of the electronic control unit.

### Claim 4 (depends on 1)

The method of claim 1, wherein the transmission of the data log is user-initiated, and the data log includes troubleshooting data for data analysis.

### Claim 5 (depends on 1)

The method of claim 1, wherein the transmission of the data log is initiated by the electronic control unit, and occurs automatically.

### Claim 6 (depends on 5)

The method of claim 5, wherein the electronic control unit initiates transmission of the data log in response to the occurrence of a fault condition.

### Claim 7 (depends on 6)

The method of claim 6, wherein the data log includes information pertaining to the fault condition.

### Claim 8 (depends on 1)

The method of claim 1, wherein the data log includes one or more parameters associated with an operating environment of the medical device during the fault or event.

### Claim 9 (depends on 1)

The method of claim 1, wherein the data log includes one or more parameters associated with performance of the medical device during the fault or event.

### Claim 10 (depends on 1)

The method of claim 1, wherein the data log includes information regarding operation of the electronic control unit during the fault or event.

### Claim 11 (depends on 1)

The method of claim 1, wherein the medical device comprises a first medical device, and further comprising installing a second set of programming instructions in a memory of a second medical device after disconnecting the first medical device from the electronic control unit.

### Claim 12 (depends on 11)

The method of claim 11, wherein the first medical device comprises an ablation device and the second medical device comprises an ablation device.

### Claim 13 (depends on 11)

The method of claim 11, wherein the second set of programming instructions is determined in part upon information contained within the data log transmitted from the memory of the electronic control unit to the memory of the first medical device.

### Claim 14 (depends on 11)

The method of claim 11, further comprising connecting the second medical device to the electronic control unit and, following the connection of the medical device to the electronic control unit, using the second set of programming instructions to overwrite at least a portion of programming instructions resident in the memory of the electronic control unit.

### Claim 15 (depends on 11)

The method of claim 11, wherein the programming instructions provide corrective information to the memory of the electronic control unit.

### Claim 16

A medical system for diagnosis or treatment of tissue, comprising:
an electronic control unit including a computer readable memory, the computer readable memory of the electronic control unit including a set of operating instructions for a medical device connected to the electronic control unit;
the medical device comprising:
an electronically-controlled tool configured for diagnosis or treatment of the tissue;
an electrical connector configured for removable connection and disconnection with the electronic control unit and configured to receive control signals upon execution of the operating instructions by the electronic control unit; and
a computer readable memory accessible through the connector,
wherein the computer readable memory of the medical device includes a set of programming instructions that changes at least a portion of the operating instructions upon connection of the medical device with the electronic control unit,
wherein the electronic control unit is configured to write a data log from the computer readable memory of the electronic control unit to the computer readable memory of the medical device during the diagnosis or treatment of the tissue upon occurrence of a fault condition, and
wherein the set of programming instructions is provided in response to data contained within the data log.

### Claim 17 (depends on 16)

The system according to claim 16, wherein the set of programming instructions permanently changes at least a portion of the operating instructions.

### Claim 18 (depends on 16)

The system according to claim 16, wherein the data log includes troubleshooting data to address the fault condition.

### Claim 19

A medical system for diagnosis or treatment of tissue, comprising:
a medical device, comprising:
an electronically-controlled tool configured for diagnosis or treatment of the tissue;
a computer readable memory including a set of operating instructions for the medical device;
an electronic control unit including a computer readable memory, wherein the electronic control unit is configured:
to copy the set of operating instructions for the medical device from the computer readable memory of the medical device into the computer readable memory of the electronic control unit upon connection of the medical device to the electronic control unit;
to deliver control signals to the medical device according to the operating instructions for the medical device copied into the computer readable memory of the electronic control unit; and
to write a data log from the computer readable memory of the electronic control unit to the computer readable memory of the medical device during the diagnosis or treatment of the tissue.

### Claim 20 (depends on 19)

The system according to claim 19, wherein the set of operating instructions are determined in part upon information contained within the data log.
