Methods and systems for controlling medical device usage

• US 10,148,439 B2
• Filed: 03/17/2014
• Issued: 12/04/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Guided Therapy Systems Llc
• Original Assignee: Ardent Sound, Inc.
• Inventors: Barthe, Peter G.
• Primary Examiner(s): Tran, Ellen
• Application Number:
  US14/777,054
• Publication Number:
  US 20160036590A1
• Time in Patent Office: 1,723 Days
• CPC Class Codes: G06F 21/606 by securing the transmission between two devices or processes
• CPC Class Codes: G06F 2221/2141 Access rights, e.g. capability lists, access control lists, access tables, access matrices
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: H04L 2209/88 Medical equipments
• CPC Class Codes: H04L 9/0891 Revocation or update of secret information, e.g. encryption key update or rekeying
• CPC Class Codes: H04L 9/3226 using a predetermined code, e.g. password, passphrase or PIN network architectures or network communication protocols for supporting authentication of entities using passwords in a packet data network H04L63/083

Abstract

Various embodiments provide systems and methods for securely transferring data from a secured site to a medical device. Some embodiments provide systems and methods for securely uploading data from a medical device to a secured site. In some embodiments described herein, data can be downloaded from a secured site to a key and after severing communication with the secured site, key can be coupled to a device and download the data to the device, in some embodiments, a public and private key pair may be used to securely download data to a device.

Claims

1. A method for using a component coupled to a medical device, the method comprising:

detaching a first component from a medical device that is in communication with a device controller;

interfacing a communication key with a computer cloud via a networked computing device while the communication key is not interfaced with the device controller;

downloading, via the networked computing device, encrypted authorization codes from the cloud onto the communication key;

severing communication between the computer cloud and the communication key by physically disconnecting the communication key from the networked computing device while the communication key is not interfaced with the device controller;

interfacing the communication key with the device controller that is in communication with the medical device after communication between the computer cloud and the communication key has been severed;

physically coupling a second component to the medical device in place of the first component;

downloading, while communication between the computer cloud and the communication key is severed, the encrypted authorization codes from the communication key to at least one of the medical device and the second component; and

initiating the second component for use when coupled to the medical device.

2. The method according to claim 1, the method further comprising determining if the component is valid using at least one of the encrypted authorization codes.

3. The method according to claim 1, the method further comprising:

operating the medical device and the component;

counting a number of treatments performed by the component during the operating the medical device and the component;

providing a limit of the number of treatments performed by the component during the operating the medical device and the component; and

disabling the component upon reaching a limit of the number of treatments performed by the component during the operating the medical device and the component.

4. The method according to claim 1, wherein the encrypted authorization codes enable operation of the component.

5. The method according to claim 1, the method further comprising:

reviewing a current version of software on the controller;

determining if a software update is available on the communication key; and

downloading the software update from the communication key to the device controller and updating the current version of software with the software update.

6. A treatment system comprising:

a secured key comprising encrypted protected memory configured to store at least a first authorization code;

a secured site located on a computing cloud and configured to securely communicate authorization codes to the secured key;

an interface configured for secured communication between the secured site and the secured key;

a treatment device;

a device controller in communication with and configured to control the treatment device, the device controller comprising a wired communication port configured for communication with the secured key; and

a component physically coupled to the treatment device and in communication with the secured key, wherein the component is associated with, and enabled to perform a treatment by, the first authorization code, and the component is configured to be detached from the treatment device to facilitate replacement with a new component associated with a second authorization code.

7. The treatment system according to claim 6, further comprising a processor configured to communicate with the secured site and comprising a second wired communication port configured for communication with the secured key.

8. The treatment system according to claim 6, wherein the component further comprises an EEPROM, and wherein the component is configured to receive the first authorization code from the secured key and communicate with the EEPROM to determine if the component is valid based on an authorization protocol and using the first authorization code.

9. The treatment system according to claim 6, further comprising:

a treatment counter embedded into the secured key and in communication with the component; and

an expiration function configured to execute after a predetermined number of treatments as clocked by the treatment counter and configured to disable operation of the component upon completion of the predetermined number of treatments.

10. The treatment system according to claim 6, further comprising a software update configured to be delivered from the secured site to the secured key and further configured to be uploaded from the secured key to the device controller and configured to update a software rev on running the device controller.

11. The treatment system according to claim 6, further comprising a firewall configured to automatically operate upon operation of the component and configured to prevent any communication to the device controller from the computer cloud.

12. A method of enabling a treatment device, the method comprising:

detaching a first component treatment module from a treatment device, wherein the first component treatment module comprises a first ultrasound transducer module and a first memory;

downloading an authorization code from a cloud computing network onto a secured electronic key;

downloading data corresponding to a new treatment method for the treatment device from the cloud computing network onto the secured electronic key;

interfacing the secured electronic key with a second component treatment module that is physically coupled to the treatment device in place of the first component treatment module, wherein the second component treatment module comprises a second ultrasound transducer module and a second memory, and is configured to perform the new treatment method;

initiating communication between the secured electronic key and the second memory of the second component treatment module;

determining if the second component treatment module is enabled to be authorized by the secured electronic key;

downloading the authorization code from the secured electronic key to the second memory of the second component treatment module;

authorizing the second component treatment module with the authorization code; and

in response to authorizing the second component treatment module, enabling operation of the treatment device physically coupled to the second component treatment module to perform the new treatment method.

13. The method according to claim 12, the method further comprising the steps of:

determining that the second component treatment module is not enabled to be authorized by the secured electronic key;

in response to determining that the second component treatment module is not enabled to be authorized by the secured electronic key, disabling the second component treatment module; and

in response to disabling the second component treatment module, preventing operation of the treatment device physically coupled to the second component treatment module.

14. The method according to claim 12, the method further comprising:

operating the treatment device physically coupled to the second component treatment module to perform the new treatment; and

counting on the secured electronic key a number of treatments performed by the second component treatment module during the operating the treatment device physically coupled to the second component treatment module.

15. The method according to claim 14, the method further comprising:

providing on the secured electronic key a limit of the number of treatments performed by the second component treatment module during the operating the treatment device physically coupled to the second component treatment module; and

disabling the second component treatment module upon reaching the limit of the number of treatments performed by the second component treatment module during the operating the treatment device physically coupled to the second component treatment module.

16. The method according to claim 12, the method further comprising establishing a communication interface between the secured electronic key and the cloud computing network before the step of downloading the authorization code from the cloud computing network onto the secured electronic key.

17. The method according to claim 16, the method further comprising severing the communication interface between the secured electronic key and the cloud computing network after the step of downloading the authorization code from the cloud computing network onto the secured electronic key.

18. The method according to claim 12, the method further comprising the steps of:

downloading a software update from the cloud computing network onto the secured electronic key;

notifying the treatment device of the software update upon the step of the initiating communication between the secured electronic key and the second component treatment module;

downloading the software update from the secured electronic key to the treatment device; and

initiating the software update on the treatment device.

19. The method according to claim 12, the method further comprising preventing the secured electronic key from interfacing with the cloud computing network upon the step of the initiating communication between the secured electronic key and the second component treatment module.

20. The method according to claim 12, the method further comprising

collecting information from the treatment device onto the secured electronic key;

and

uploading the information from the secured key to the cloud computing network, wherein the information comprises at least one of treatment logs, diagnostic information, and treatment device usage.