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

• US 10,057,066 B2
• Filed: 03/07/2018
• Issued: 08/21/2018
• 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
• Application Number:
  US15/914,007
• Publication Number:
  US 20180198623A1
• Time in Patent Office: 167 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. A system, comprising:

an ultrasound imaging catheter configured to obtain image data of a lumen within a patient, the ultrasound imaging catheter comprising a memory configured for communication with one or more computing systems to access the memory to;

permit an authorized first use and an authorized second use of the ultrasound imaging catheter in a first clinical procedure and a second clinical procedure, respectively;

authorize the first use of the ultrasound imaging catheter during the first clinical procedure;

permit reconditioning of the ultrasound imaging catheter, based on authorization with a key, after the first use of the ultrasound imaging catheter in the first clinical procedure; and

authorize the second use of the ultrasound imaging catheter during the second clinical procedure.

2. The system of claim 1, wherein the one or more computing systems comprise a remote computing system.

3. The system of claim 1, wherein the ultrasound imaging catheter is useable for a limited number of times including the authorized first use and the authorized second use.

4. The system of claim 1, wherein at least one of the one or more computing systems has access to the key to permit the reconditioning of the ultrasound imaging catheter.

5. The system of claim 4, wherein the key is changeable such that at least one of the one or more computing systems has access to a different key.

6. The system of claim 1, wherein at least one of the one or more computing systems has access to an array of keys to permit the reconditioning of a plurality of ultrasound imaging catheters.

7. The system of claim 1, wherein the key is changeable via software associated with the one or more computing systems.

8. The system of claim 1, wherein the memory is accessed by at least one of the one or more computing systems during the second clinical procedure to determine if the ultrasound imaging catheter is within a reuse window.

9. The system of claim 1, wherein access to the memory by the one or more computing systems comprises a read or a write.

10. The system of claim 9,

wherein the memory is written to, to permit the authorized first use and the authorized second use of the ultrasound imaging catheter in the first clinical procedure and the second clinical procedure, respectively, by a first computing system of the one or more computing systems,

wherein the memory is read during the first clinical procedure to authorize the first use of the ultrasound imaging catheter, by a second computing system of the one or more computing systems,

wherein the memory is written to, to permit reconditioning of the ultrasound imaging catheter after the first use of the ultrasound imaging catheter in the first clinical procedure, by the second computing system, and

wherein the memory is read during the second clinical procedure, by a third computing system of the one or more computing systems.

11. The system of claim 10, wherein the first computing system is different from the second computing system.

12. The system of claim 1, further comprising the one or more computing systems.