Radio frequency identification monitoring of stents

• US 10,145,811 B2
• Filed: 09/05/2017
• Issued: 12/04/2018
• Est. Priority Date: 07/13/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Freeman, Abigail, Gale, David C., Huang, Bin, Castro, Daniel
• Primary Examiner(s): West, Paul M.
• Assistant Examiner(s): Shabman, Mark A
• Application Number:
  US15/695,776
• Publication Number:
  US 20170363554A1
• Time in Patent Office: 455 Days
• Field of Search: None
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0085 Identification means; Administration of patients
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/082 X-rays
• CPC Class Codes: A61L 2/085 Infrared radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: G01N 25/72 Investigating presence of flaws

Abstract

A method and system of monitoring environmental exposure of stents using radiofrequency identification is disclosed.

Claims

1. A system for monitoring a stent comprising:

an implantable medical device disposed within a sealed container, wherein the device comprises a bioabsorbable stent crimped over a delivery balloon, wherein the stent comprises a scaffolding including a network of interconnecting structural elements that comprise a polylactide-based polymer;

a sensor disposed within or on the sealed container capable of monitoring a temperature of exposure of the device, wherein the monitored temperature is compared to a temperature tolerance stored on the device and when the temperature tolerance is exceeded, an alert is generated.

2. The system of claim 1, wherein exceeding the temperature tolerance comprises exceeding a maximum temperature.

3. The system of claim 1, wherein exceeding the temperature tolerance comprises exceeding a time-temperature tolerance comprising a maximum time above a selected temperature.

4. The system of claim 1, wherein the container is disposed within a box and the container is a foil pouch.

5. The system of claim 1, wherein the sensor is integrated with an RFID tag which monitors conditions of exposure and records data.

6. The system of claim 1, wherein the sensor is positioned less than 8 mm from stent.

7. The system of claim 1, further comprising an RFID tag capable of storing and transmitting the monitored temperature.

8. The system of claim 7, wherein the RFID tag is configured to receive data from the sensor.

9. The system of claim 7, wherein the RFID tag is configured to transmit data to a transceiver which transmits data from the sensor to a storage and processing system.

10. The system of claim 7, wherein the sensor and RFID tag are communicatively coupled directly or wirelessly.

11. The system of claim 7, wherein the RFID tag is communicatively coupled with a transceiver and is configured to transmit data from the sensor to the transceiver directly or wirelessly.

12. The system of claim 11, wherein the transceiver is incorporated into a hand-device.

13. The system of claim 11, wherein the transceiver is at a location where stents are stored, the location selected from the group consisting of a refrigerator, freezer, within a cargo container, within a truck, within an airplane, and within a train.

14. The system of claim 11, wherein the transceiver is configured to transmit data it receives to a processing system.

15. The system of claim 14, wherein the processing system is selected from the group consisting of a desktop, laptop, mainframe, and PDA.