Single use medical devices

• US 9,649,014 B2
• Filed: 04/26/2011
• Issued: 05/16/2017
• Est. Priority Date: 04/28/2010
• Status: Active Grant

• Current Assignee: UroViu Corp.
• Original Assignee: Avram Allan Edidin, Xiaolong Ouyang
• Inventors: Edidin, Avram Allan, Ouyang, Xiaolong, Tian, Hui
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US13/094,415
• Publication Number:
  US 20110270179A1
• Time in Patent Office: 2,212 Days
• Field of Search: 604110, 34823199, 3482221, 348 E5024, 348 E5031, 327525, 326 6, 396 16- 17
• CPC Class Codes: A61B 1/00062 provided with means for preventing overuse
• CPC Class Codes: A61B 1/00124 electrical, e.g. electrical plug-and-socket connection

Abstract

A single use medical device can include a single use medical device module configured for use within a body of a subject receiving a medical procedure. It can also include an electronic component having a one-time programmable (“OTP”) component that is configured to render the single use medical device module unusable after being used in the medical procedure in the subject.

Claims

1. A single use medical device comprising:

a single use medical device module configured for use within a body of a subject receiving a medical procedure, the single use medical device module comprising;

an electronic component having a one-time programmable (“

OTP”

) component that is configured to render the single use medical device module unusable after being used in the medical procedure in the subject.

2. The single use medical device of claim 1, wherein the electronic component includes an image sensor.

3. The single use medical device of claim 1, wherein the OTP component is operably coupled with the electronic component.

4. The single use medical device of claim 1, wherein the OTP component is contained within the electronic component.

5. The single use medical device of claim 2, wherein the electronic component is configured as a CMOS image sensor.

6. The single use medical device of claim 1, wherein the OTP component is configured to operate one time, and thereafter it does not allow the single use medical device to operate.

7. The single use medical device of claim 1, wherein the OTP component includes a self-sacrificing module (SSM) that self-destructs after being used one time.

8. The single use medical device of claim 1, wherein the OTP component is operably coupled with a timer and an AND circuit, when the timer reaches a certain time, the single use medical device no longer works.

9. The single use medical device of claim 1, wherein the OTP component includes a disabling bit (DB) circuit that is programmed to disable the single use medical device when a Clock_out signal is received by the DB circuit.

10. The single use medical device of claim 1, wherein the OTP component is configured to control various electronic components of the medical device within the single use medical device module.

11. The single use medical device of claim 1, wherein the OTP component is configured to be programmed one time by various electronic components of the medical device within the single use medical device module.

12. The single use medical device of claim 1, wherein the OTP component is configured such that a state change of a signal to the OTP component disables the single use medical device module.

13. The single use medical device of claim 1, comprising a controller configured to program the OTP with system time stamp and an ID generated from Patient ID.

14. The single use medical device of claim 1, comprising a controller configured to read the serial number of one or more electronics modules of the single use medical device module.

15. The single use medical device of claim 1, comprising a controller configured to tag a serial number of one or more electronics modules of the single use medical device module, and associate the serial number with a Patient ID.

16. The single use medical device of claim 1, wherein the electronic component having the OTP component includes an algorithm that is processed in order to render the single use medical device module unusable after being used in the medical procedure in the subject.

17. The single use medical device of claim 1, wherein the algorithm is configured to process data in order to detect and/or determine if the OTP component has been programmed.

18. The single use medical device of claim 1, wherein the single use medical device module is configured to disable an image sensor by one or more of the following:

disabling a clock (CLK) to a chip of the image sensor, the chip being operably coupled with the OTP component;

disabling a digital enabling Den inside the image sensor;

or

changing a state of the OTP component with “

self-destroy”

codes.

19. A medical device comprising:

a reusable portion; and

a single use portion comprising the single use medical device of claim 1.

20. In a medical device system comprising a reusable medical device and the single use medical device of claim 1, with the reusable medical device removably receiving the single use medical device, a method of operating the single use medical device, the method comprising:

using the single use medical device;

programming the OTP component; and

terminating use of the single use medical device.

21. The method of claim 20, further comprising:

attempting to reuse the single use medical device, the single use medical device being unusable.

22. The method of claim 20, further comprising:

the single use medical device providing an indication that the single use medical device has already been used or that the single use medical device is not operational.

23. The method of claim 20, further comprising:

generating a first unique case identifier corresponding to a first unique patient undergoing a medical procedure;

obtaining a first time stamp representing a current time; and

determining that the OTP component has previously been programmed with a second unique case identifier and a second time stamp, when the first unique case identifier is different than the second unique case identifier, or when the amount of time elapsed from an initial time represented by the second time stamp to a subsequent time represented by the first time stamp is greater than a predetermined amount of time, disabling the single use medical device module by programming a disabling bit on the one-time programmable chip;

or

determining that the OTP component has not been previously programmed, wherein the single use medical device module is operational.