Systems and methods for monitoring and controlling use of medical devices

• US 9,925,000 B2
• Filed: 09/25/2015
• Issued: 03/27/2018
• 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, Qin, Jay, Gaiser, John, Utley, David S., Bernitt, James J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US14/866,632
• Publication Number:
  US 20160015449A1
• Time in Patent Office: 914 Days
• 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 18/1477 Needle-like probes
• 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 2018/0022 Balloons
• 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 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• 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 device carries a use monitoring element that possesses a state or condition that changes in response to use of the device and that is sensed when the device is presented for use. Reuse of the device is not permitted, if the use monitoring element indicates a prior use.

Claims

1. A system for treating a tissue region comprising:

a device including a handle and an element within the handle holding a unique identification code; and

a controller registering the unique identification code when the device is coupled to the controller, the controller further maintaining a use table containing prior identification codes that meet a criteria to be registered by the controller, the controller comparing the unique identification code of the device coupled thereto to the prior identification codes to detect an absence or a presence of a match, in the absence of the match the controller updates the use table by adding the unique identification code to the use table and enables use of a generator associated with the device, and in the presence of the match the controller does not add the unique identification code to use table.

2. The system of claim 1, wherein the controller outputs to a display device notice of prior use of the device.

3. The system of claim 2, wherein the notice is an alarm.

4. The system of claim 1, wherein in the presence of the match the controller does not enable use of the generator associated with the device.

5. The system of claim 2, wherein in the presence of the match the controller does not enable use of the generator associated with the device.

6. The system of claim 5, wherein the controller maintains for each registered identification code in the use table a time record, the time record contains a value reflecting a period of time during which energy was applied by the generator in a permitted use, and when the match occurs between the unique identification code and the prior identification codes the controller ascertains whether the time period of prior use is less than a prescribed maximum time period and if so, enables a subsequent operation of the generator.

7. The system of claim 6, wherein the controller maintains for each registered identification code in the use table a time record, the time record contains a value reflecting a period of time during which energy was applied by the generator in a permitted use, and when the match occurs between the unique identification code and the prior identification codes the controller ascertains whether the time period of prior use is less than a prescribed maximum time period and if so, enables a subsequent operation of the generator.

8. The system of claim 6, wherein the controller updates the time record as further use occurs.

9. The system of claim 8, wherein the controller outputs to a display device a time period of permitted use remaining.

10. The system of claim 6, wherein if the time period of prior use ascertained by the controller exceeds a prescribed maximum time period, the controller does not enable use of the generator.

11. The system of claim 10, wherein the controller outputs to a display device notice of prior use.

12. The system of claim 1, wherein the device includes an expandable structure at a distal portion.

13. The system of claim 11, wherein the device includes a plurality of electrodes movable from a retracted position to an extended position.

14. The system of claim 13, wherein the device includes temperature sensors associated with electrodes.