Systems and methods for monitoring and controlling use of medical devices

• US 8,449,529 B2
• Filed: 12/08/2008
• Issued: 05/28/2013
• Est. Priority Date: 09/08/1999
• Status: Expired due to Fees

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Inventors: Bek, Robin, Gaiser, John, Qin, Jay, Utley, David S
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US12/315,890
• Publication Number:
  US 20090093805A1
• Time in Patent Office: 1,632 Days
• Field of Search: 606/1, 606 32- 34, 606/41, 606 45- 50
• US Class Current: 606/1
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags

Abstract

A usage key card is adapted to be handled separate from a device tissue treatment device. The usage key card has a storage medium formatted to contain an identification code, which is unique to the usage key card. The usage key card is also adapted to be read by a reader separate from the device. The storage medium is also formatted, when inserted into the reader, to retain data generated pertaining to operation of the device.

Claims

1. A system comprising

a device for treating a tissue region, and

a usage key card not connected to the device to be handled separate from the device comprising a storage medium formatted to contain an identification code uniquely assigned to the device, the identification code being unique to the usage key card, the usage key card being adapted to be read by a reader separate from the device, the storage medium being also formatted, when inserted into the reader, to retain data generated during operation of the device pertaining to operation of the device, the reader downloading the identification code to a controller to update a use table and register the identification code if not previously registered upon being downloaded to enable use of the device upon being registered.

2. A system according to claim 1

wherein the usage key card comprises a floppy disk.

3. A system according to claim 1

wherein the usage key card comprises a PC card.

4. A system according to claim 1

wherein the usage key card comprises a magnetic card.

5. A system according to claim 1

wherein the usage key card comprises flash memory.

6. A system according to claim 1

wherein the device applies radio frequency energy to the tissue region.

7. A system according to claim 1

wherein when the usage key card is inserted into the reader and the reader downloads the identification code to the controller the use table is not updated if the identification code is previously registered.

8. A system according to claim 1

wherein the storage medium contains at least first and second pre-formatted files, the first file containing the identification code and the second file containing operational and performance data.

9. A system according to claim 8

wherein the second file receives data generated by the controller during permitted use of the device.

10. A system according to claim 9

wherein the second file retains the data in a formatted array to create a procedure log.

11. A system according to claim 10

wherein the procedure log documents by date of treatment a magnitude of energy delivered by the device.

12. A system according to claim 10

wherein the procedure log documents by date of treatment a time duration of energy application.

13. A system comprising

a device for treating a tissue region;

and

a storage medium associated with the device, the storage medium formatted to contain an identification code uniquely assigned to the device, the storage medium adapted to be read by a reader separate from the device for downloading the identification code to a controller to enable the controller to add to its registry the downloaded identification code if not already in its registry upon being downloaded to enable use of the device upon being added to its registry and to not add the identification code to its registry if already in its registry.

14. A system according to claim 13

wherein the storage medium contains at least first and second pre-formatted files, the first file containing the identification code and the second file containing operational and performance data.

15. A system according to claim 14

wherein the second file receives data generated by the controller during permitted use of the device.

16. A system according to claim 15

wherein the second file retains the data in a formatted array to create a procedure log.

17. A system according to claim 16

wherein the procedure log documents by date of treatment a magnitude of energy delivered by the device.

18. A system according to claim 16

wherein the procedure log documents by date of treatment a time duration of energy application.