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

• US 9,445,723 B2
• Filed: 04/08/2015
• Issued: 09/20/2016
• 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:
  US14/681,892
• Publication Number:
  US 20150289944A1
• Time in Patent Office: 531 Days
• US Class Current: 1/1
• 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. A method of reconditioning an intravascular device for reuse during a clinical procedure, comprising:

reading first security data from a memory of the intravascular device;

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

generating second security data, when the intravascular device is authentic; and

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

2. The method of claim 1, further comprising:

terminating the reconditioning when the intravascular device is determined to be not authentic.

3. The method of claim 1, further comprising:

sterilizing the intravascular device.

4. The method of claim 1, further comprising:

evaluating performance characteristics of the intravascular device; and

generating reuse instructions for the intravascular device based on the performance characteristics.

5. The method of claim 1, further comprising:

reading first device data from the memory of the intravascular device, the first device data including at least one of;

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

6. The method of claim 5, further comprising:

generating second device data, the second device including at least one of;

a serial number, additional configuration information, additional parameters, a recondition date, reuse instructions, performance parameters, a version number, an expiration date, and system configuration settings; and

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

7. The method of claim 6, wherein the first and second security data include a message authentication code.

8. The method of claim 6, wherein the first security data is generated using a secret key, the first device data, and the serial number.

9. The method of claim 6, wherein the second security data is generated using a secret key, the second device data, and the serial number.

10. An intravascular system, comprising:

a computing device in communication with an intravascular device, the computing device being configured to recondition the intravascular device for reuse during a clinical procedure by;

reading first security data from a memory of the intravascular device;

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

generating second security data, when the intravascular device is authentic; and

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

11. The intravascular system of claim 10, wherein the computing device is further configured to:

evaluate performance characteristics of the intravascular device; and

generate reuse instructions for the intravascular device based on the performance characteristics.

12. The intravascular system of claim 10, wherein the computing device is further configured to:

read first device data from the memory of the intravascular device, the first device data including at least one of;

a serial number, a manufacturing date, configuration information, initial parameters, a manufacture date, performance parameters, a version number, an expiration date, and system configuration settings;

generate second device data, the second device data including at least one of;

a serial number, additional configuration information, additional parameters, a recondition date, reuse instructions, performance parameters, a version number, an expiration date, and system configuration settings; and

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

13. The intravascular system of claim 12, wherein the computing device is further configured to generate the second security data by generating a message authentication code.

14. The intravascular system of claim 13, wherein the computing device is further configured to generate the second security data by using a secret key, the second device data, and the serial number.

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

bringing an intravascular device into communication with a computing device, the intravascular device including a memory accessible by the computing device, the memory having first device data, second device data, first security data, and second security data stored thereon;

determining if first security data is authentic based on the first device data;

determining, when the first security data is authentic, if the intravascular device has been reconditioned based on the second device data;

determining, when the intravascular device has been reconditioned, if the second security data is authentic based on the second device data; and

permitting, when second security data is authentic, use of the intravascular device in the clinical procedure.

16. The method of claim 15, further comprising:

determining if the intravascular device is within an authorized period of use based on at least one of the first device data and the second device data; and

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

17. The method of claim 15, wherein the first and second security data include a message authentication code, wherein the first security data is generated using a secret key, the first device data, and a serial number of the memory, and the second security data is generated using the secret key, the second device data, and the serial number of the memory.

18. An intravascular system, comprising:

a computing device in communication with an intravascular device having a memory, the computing device being configured to authenticate the intravascular device for use during a clinical procedure by;

determining if first security data stored on the memory is authentic based on first device data stored on the memory;

determining, when the first security data is authentic, if the intravascular device has been reconditioned based on second device data stored on the memory;

determining, when the intravascular device has been reconditioned, if second security data stored on the memory is authentic based on the second device data; and

permitting, when second security data is authentic, use of the intravascular device in the clinical procedure.

19. The intravascular system of claim 18, wherein the computing device is further configured to:

determine if the intravascular device is within an authorized period of use based on at least one of the first device data and the second device data; and

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

20. The intravascular system of claim 18, wherein the first and second security data include a message authentication code, wherein the first security data is generated using a secret key, the first device data, and a serial number of the memory, and the second security data is generated using the secret key, the second device data, and the serial number of the memory.