Devices, systems, and methods for authenticated intravascular device use and reuse

• US 9,948,466 B2
• Filed: 09/19/2016
• Issued: 04/17/2018
• Est. Priority Date: 04/09/2014
• Status: Active Grant

• Current Assignee: Philips Image Guided Therapy Corporation (Koninklijke Philips N.V.)
• Original Assignee: Koninklijke Philips N.V.
• Inventors: Hoffman, Joseph, Spencer, Jason
• Primary Examiner(s): ODOM, CURTIS B
• Application Number:
  US15/269,692
• Publication Number:
  US 20170012779A1
• Time in Patent Office: 575 Days
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/027 using catheters
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: H04L 9/3242 involving keyed hash functions, e.g. message authentication codes [MACs], CBC-MAC or HMAC

Abstract

Devices, systems, and methods for reconditioning an intravascular device for reuse are provided. The method includes reading first security data from a memory of the intravascular device; determining if the intravascular device is authentic; generating second security data, when the intravascular device is authentic; and writing the second security data to the memory of the intravascular device. Devices, systems, and methods for authenticating an intravascular device for use are also provided. The method includes bringing an intravascular device into communication with a computing device, the intravascular device including a memory; determining if first security data is authentic; determining, when the first security data is authentic, if the intravascular device has been reconditioned; determining, when the intravascular device has been reconditioned, if the second security data is authentic base; and permitting, when second security data is authentic, use of the intravascular device in the clinical procedure.

Claims

1. An intravascular system, comprising:

an intravascular device including a memory, wherein the memory includes;

device data associated with the intravascular device;

security data generated based on the device data and a secret key, wherein the security data including a message authentication code (MAC);

a computing device in communication with the memory, wherein the computing device operable to;

determine if the intravascular device is authentic based on the device data and the security data;

determine if the intravascular device is within an authorized period of use based on the device data; and

permit, when the security data is authentic and the intravascular device is within the authorized period of use, use of the intravascular device in the clinical procedure.

2. The intravascular system of claim 1, wherein the device data includes at least one of:

a serial number, configuration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, or system configuration settings.

3. The system of claim 1, wherein the security data is associated with a cipher-based message authentication (CMAC) algorithm.

4. The system of claim 1, wherein the security data is associated with a 128-bit advanced encryption standard (AES) algorithm.

5. The system of claim 1, wherein the intravascular device further includes a component operable to obtain at least one of image data, pressure data, or flow data.

6. The system of claim 1, wherein the intravascular device includes at least one of a guide wire, a catheter, or a guide catheter.

7. The system of claim 1, wherein a further computing device is operable to:

generate the device data associated with the intravascular device;

write the device data to the memory of the intravascular device;

generate the security data; and

write the security data to the memory of the intravascular device.

8. The system of claim 7, wherein the further computing device is operable to generate the security data using a serial number.

9. The system of claim 7, wherein the further computing device is further operable to prevent editing of a portion of the memory storing the device data and the security data.

10. A method of authenticating an intravascular device for use during a clinical procedure, the method comprising:

establishing communication between a computing device and an intravascular device including a memory accessible by the computing device, the memory including;

device data associated with the intravascular device; and

security data generated based on the device data and a secret key, wherein the security data includes a message authentication code (MAC);

determining if the intravascular device is authentic based on the device data and the security data;

determining if the intravascular device is within an authorized period of use based on the device data; and

permitting, when the security data is authentic and the intravascular device is within the authorized period of use, use of the intravascular device in the clinical procedure.

11. The method of claim 10, wherein the device data includes at least one of:

a serial number, configuration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, or system configuration settings.

12. The method of claim 10, wherein the security data is associated with a cipher-based message authentication (CMAC) algorithm.

13. The method of claim 10, wherein the security data is associated with a 128-bit advanced encryption standard (AES) algorithm.

14. The method of claim 10, wherein the intravascular device further includes a component operable to obtain at least one of image data, pressure data, or flow data.

15. The method of claim 10, wherein the intravascular device includes at least one of a guide wire, a catheter, or a guide catheter.

16. The method of claim 10, further comprising:

generating the device data associated with the intravascular device;

writing the device data to the memory of the intravascular device;

generating the security data; and

writing the security data to the memory of the intravascular device.

17. The method of claim 16, wherein the generating the security data includes generating the security data using a serial number.

18. The method of claim 16, further comprising:

preventing editing of a portion of the memory of the intravascular device storing the device data and the security data.