# US 12,642,976 B2 · Systems and methods for establishing secure communications between medical device system components

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- Number: US 12,642,976 B2
- Document ID: US12642976B2
- Status: Granted
- Kind: B2
- Application number: 18/200,987
- Filed: 2023-05-23
- Published: 2023-11-30
- Granted: 2026-06-02
- Earliest claimed: 2022-05-27
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Daniel Joseph Landherr; Ron A. Balczewski; Keith R. Maile; William J. Linder
- Web page: https://patentgrep.com/patent/US12642976B2

## CPC

- A61N 1/37229: {Shape or location of the implanted or external antenna}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- A61N 1/37254: {Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals}
- A61N 1/3787: {from an external energy source}
- 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

Embodiments herein relate to medical device systems including features to enable secure wireless communications between components thereof. In an embodiment, a medical device system is included having an implantable medical device packaging unit and an implantable device. The implantable device can include a control circuit and a communications antenna. The implantable device can be configured to fit within the implantable medical device packaging unit prior to implantation in a patient. The system can also include a data bearing tag, wherein the data bearing tag is disposed on or in the implantable medical device packaging unit. In some embodiments the system can also include an external communication device. The external communication device can be configured to receive data from the data bearing tag enabling secure wireless communications between the implantable device and the external communication device. Other embodiments are also included herein.

## Claims

### Claim 1

A medical device system comprising:
an implantable medical device packaging unit; and
an implantable device, the implantable device comprising
a control circuit; and
a communications antenna, wherein the communications antenna is in electrical communication with the control circuit;
wherein the implantable device is configured to fit within the implantable medical device packaging unit prior to implantation in a patient;
a data bearing tag, wherein the data bearing tag is disposed on or in the implantable medical device packaging unit; and
an external communication device, wherein the external communication device is configured to receive data from the data bearing tag enabling secure wireless communications between the implantable device and the external communication device.

### Claim 2 (depends on 1)

The medical device system of claim 1, the data bearing tag comprising at least one selected from the group consisting of an NFC tag, an optically recognizable code, and an RFID tag.

### Claim 3 (depends on 2)

The medical device system of claim 2, the optically recognizable code comprising a QR code.

### Claim 4 (depends on 2)

The medical device system of claim 2, the NFC tag comprising a passive NFC tag.

### Claim 5 (depends on 1)

The medical device system of claim 1, the data bearing tag comprising data in the form of a character string.

### Claim 6 (depends on 1)

The medical device system of claim 1, the data bearing tag comprising data in the form of at least one of a cryptography key and a digital certificate.

### Claim 7 (depends on 1)

The medical device system of claim 1, the implantable medical device packaging unit comprising electromagnetic shielding.

### Claim 8 (depends on 1)

The medical device system of claim 1, the implantable device comprising at least one selected from the group consisting of an implantable monitor, a cardiac rhythm management device, and a neuromodulation device.

### Claim 9 (depends on 1)

The medical device system of claim 1, wherein the data bearing tag is configured to be inoperative until the implantable medical device packaging unit is opened.

### Claim 10 (depends on 9)

The medical device system of claim 9, wherein the data bearing tag is configured to communicate via wireless electromagnetic modalities, and wherein electromagnetic shielding prevents wireless communication with the data bearing tag until the implantable medical device packaging unit is opened.

### Claim 11 (depends on 1)

The medical device system of claim 1, further comprising a second data bearing tag, wherein the external communication device is configured to receive data from the data bearing tag and the second data bearing tag enabling secure wireless communications between the implantable device and the external communication device.

### Claim 12 (depends on 11)

The medical device system of claim 11, the data bearing tag and the second data bearing tag each comprising different data required to establish secure communications, wherein the data bearing tag and the second data bearing tag must be read to enable secure communications.

### Claim 13

A medical device system comprising:
an implantable device, the implantable device comprising
a control circuit; and
a communications antenna, wherein the communications antenna is in electrical communication with the control circuit;
a data bearing tag, wherein the data bearing tag is disposed on or in the implantable device; and
an external communication device, wherein the external communication device is configured to receive data from the data bearing tag enabling secure wireless communications between the implantable device and the external communication device.

### Claim 14 (depends on 13)

The medical device system of claim 13, the data bearing tag comprising at least one selected from the group consisting of an NFC tag, an optically recognizable code, and an RFID tag.

### Claim 15 (depends on 14)

The medical device system of claim 14, the optically recognizable code comprising a QR code.

### Claim 16 (depends on 14)

The medical device system of claim 14, the NFC tag comprising a passive NFC tag.

### Claim 17 (depends on 13)

The medical device system of claim 13, the data bearing tag comprising data in the form of a character string.

### Claim 18 (depends on 13)

The medical device system of claim 13, the data bearing tag comprising data in the form of at least one of a cryptography key and a digital certificate.

### Claim 19 (depends on 13)

The medical device system of claim 13, the implantable device comprising at least one selected from the group consisting of an implantable monitor, a cardiac rhythm management device, and a neuromodulation device.

### Claim 20 (depends on 13)

The medical device system of claim 13, the implantable device comprising a header structure, wherein the data bearing tag is disposed on or within the header structure.