# US 12,217,860 B2 · Medical implant software systems and methods

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- Number: US 12,217,860 B2
- Document ID: US12217860B2
- Status: Granted
- Kind: B2
- Application number: 18/442,614
- Filed: 2024-02-15
- Published: 2024-07-25
- Granted: 2025-02-04
- Earliest claimed: 2022-06-24
- Assignees: CraniUS LLC
- Applicants: CraniUS LLC
- Inventors: Conner Delahanty; Aayush Gandhi; Rahul Gangwani; Maximilian Zinkus; Simone Bliss; Tiger Gao; Owen Friesen; John Cai; Vivian Looi; Isaac Lefkovitz
- Web page: https://patentgrep.com/patent/US12217860B2

## CPC

- G16H 20/17: delivered via infusion or injection
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 80/00: ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
- H04W 12/037: of the control plane, e.g. signalling traffic
- H04W 12/50: Secure pairing of devices
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04W: WIRELESS COMMUNICATION NETWORKS (broadcast communication H04H; communication systems using wireless links for non-selective communication, e.g. wireless extensions H04M1/72)

## Abstract

A method for remotely bonding a companion device to an implanted medical device to achieve long-term encrypted and authenticated communication channel, that is resilient to companion device failure or compromise and hence mitigates the risk or need for unplanned, revision surgery and/or premature device explantation. Through use of a shared cryptographic key between the two systems, the companion device may request an encrypted challenge number from the implant. Completing the challenge via transmitting an encrypted validation number permits the implanted medical device to bond and perform a new long-term key exchange. The shared cryptographic key can be changed as well, in event of compromise or other adverse event, using a described device firmware update procedure.

## Claims

### Claim 1

A method for remotely bonding a companion device to an implanted medical device, comprising:
periodically determining if the companion device is bonded to the implanted medical device;
when no device is bonded to the implanted medical device, advertising a periodic signal containing an encrypted number from the implanted medical device, wherein the encrypted number is encrypted by a cryptographic key associated with the implanted medical device;
receiving, by the companion device, the periodic bonding signal from the implanted medical device;
decrypting, by the companion device, the encrypted number transmitted by the periodic bonding signal data using the cryptographic key information, resulting in a decrypted number; creating, by the companion device, a response to the decrypted number; encrypting, by the companion device, the response to the decrypted number;
transmitting the encrypted response to the decrypted number to the implanted medical device;
validating, by the implanted medical device, the transmitted response;
triggering the implanted medical device to accept and establishing new bonded connections between the companion device and the implanted medical device; and
monitoring and/or diagnosing a patient's health conditions with the implanted medical device by:
detecting a cause for concern;
sending, to the companion device through the bonded connection, an alert about the cause for concern;
wherein the cause for concern is that the implanted medical device has been compromised;
wherein the implanted medical device is configured to automatically break the connection to the companion device and continue to save all relevant data to internal storage when the implanted medical device has been compromised; and
wherein the cryptographic key information associated with the implanted medical device is provided to the companion device by a build machine at the time the companion device is manufactured.

### Claim 2 (depends on 1)

The method of remotely bonding of claim 1, wherein the bonded connection between the companion device and the implanted medical device is a direct short-range wireless connection.

### Claim 3 (depends on 2)

The method of remotely bonding of claim 2, wherein the implanted medical device is a craniofacial implant and the companion device is a tablet.

### Claim 4 (depends on 1)

The method of remotely bonding of claim 1, wherein the implanted medical device is physically inaccessible.

### Claim 5 (depends on 1)

The method of remotely bonding of claim 1, wherein the implanted medical device is one of a spine implant or an orthopedic joint implant and the companion device is a tablet.

### Claim 6

A system for remotely bonding a companion device to an implanted medical device, comprising;
the implanted medical device periodically determines if the companion device is bonded to the implanted medical device, wherein if no device is bonded to the implanted medical the implanted medical device periodically advertises a signal containing an encrypted number that is encrypted by a cryptographic key associated with the implanted medical device;
a companion device which is provided with the cryptographic key associated with the implanted medical device and which receives the periodic bonding signal from the implanted medical device, determines a decrypted number by decrypting the encrypted number using the cryptographic key information, creates a response to the decrypted number, encrypts the response to the decrypted number, and transmits the encrypted response to the decrypted number to the implanted medical device;
wherein the implanted medical device validates the transmitted response and establishes a bonded connection between the companion device and the implanted medical device;
wherein the implanted medical device monitors and/or diagnoses a patient's health conditions and detects causes for concerns,
wherein the cause for concern is that the implanted medical device has been compromised;
sending, to the companion device through the bonded connection, an alert about the cause for concern; and
wherein the implanted medical device is configured to automatically break the connection to the companion device and continue to save all relevant data to internal storage when the implanted medical device has been compromised; and
a build machine that provides the cryptographic key information associated with the implanted medical device to the companion device at the time the companion device is manufactured.

### Claim 7 (depends on 6)

The system for remotely bonding of claim 6, wherein the bonded connection between the companion device and the implanted medical device is a direct short-range wireless connection.

### Claim 8 (depends on 7)

The system for remotely bonding of claim 7, wherein the implanted medical device is a craniofacial implant and the companion device is a tablet.

### Claim 9 (depends on 6)

The system for remotely bonding of claim 6, wherein the implanted medical device is physically inaccessible.

### Claim 10 (depends on 6)

The system for remotely bonding of claim 6, wherein the implanted medical device is one of a spine implant or an orthopedic joint implant and the companion device is a tablet.