Single use medical devices

• US 10,426,320 B2
• Filed: 04/11/2017
• Issued: 10/01/2019
• Est. Priority Date: 04/28/2010
• Status: Active Grant

• Current Assignee: UroViu Corp.
• Original Assignee: Xiaolong Ouyang
• Inventors: Ouyang, Xiaolong, Edidin, Avram Allan, Tian, Hui
• Primary Examiner(s): Vu, Quynh-Nhu H.
• Application Number:
  US15/484,953
• Publication Number:
  US 20170215699A1
• Time in Patent Office: 903 Days
• CPC Class Codes: A61B 1/00009 of image signals during a use of endoscope
• CPC Class Codes: A61B 1/0002 provided with data storages
• CPC Class Codes: A61B 1/00045 Display arrangement
• 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
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

A single use medical device can include a single use medical device module configured for use in a medical procedure. The single use medical device 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. The single use medical device can also include a self-sacrificing module (SSM) that is configured to self-destruct and render the single use medical device unusable upon being cleaned or sterilized after being used in the medical procedure in the subject. The SSM can be operably coupled with a system controller module (SCM), which can read the state of the SSM and determine whether or not the medical device has undergone cleaning or sterilization.

Claims

1. A device comprising:

a self-sacrificing module (SSM) that is configured to self-destruct and render the device unusable upon being cleaned or sterilized;

wherein the SSM is operably coupled to a around electronic line and a clock line, when inactivated the SSM does not electronically couple the around electronic line and the clock line, when activated the SSM electronically couples the around electronic line and the clock line.

2. The device of claim 1, wherein the SSM is operably coupled with one or more electronic components in the device.

3. The device of claim 2, wherein the SSM is operably coupled with a system controller module (SCM).

4. The device of claim 1, wherein the SSM is operably coupled to a ground electronic line.

5. The device of claim 1, wherein the SSM is located within an electronic circuit of the device and activation of the SSM causes an electronic circuit to open or close to render the device unusable.

6. The device of claim 1, the SSM comprising a biasing mechanism including a biasing element and first and second electrically conductive elements spaced apart by the biasing element, when the SSM is inactivated the first electrically conductive element does not electronically couple with the second electrically conductive element, when the SSM is activated the biasing element electronically couples the first electrically conductive element with the second electrically conductive element.

7. The device of claim 6, the SSM comprising a degradable member positioned between the first electrically conductive element and the second electrically conductive element, when the degradable member degrades, the biasing element electronically couples the first electrically conductive element with the second electrically conductive element.

8. The device of claim 7, wherein the degradable member degrades in response to heat, ionization, chemicals, liquid, aqueous solution, or radiation.

9. The device of claim 1, the SSM comprising an electrically conductive degradable member positioned between and electrically coupling a first electrically conductive element and a second electrically conductive element, when the conductive degradable member degrades, the first electrically conductive element electrically uncouples with the second electrically conductive element.

10. The device of claim 9, the SSM comprising a biasing element biased against the electrically conducive degradable member, when the SSM is activated the biasing element breaks the electrically conductive degradable member so that the first electrically conductive element is not electrically coupled with the second electrically conductive element.

11. The device of claim 9, wherein the electrically conductive degradable member degrades in response to heat, ionization, chemicals, liquid, aqueous solution, or radiation.

12. The device of claim 1, the SSM comprising an electrically conductive member having an electrically conductive state and an electrically non-conductive state, the electrically conducive member being positioned between and electrically coupling a first electrically conductive element and a second electrically conductive element, wherein the electrically conductive member changes from the electrically conductive state to the electrically non-conductive state when exposed to a chemical, when in the electrically non-conductive state the first electrically conductive element is electrically uncoupled from the second electrically conductive element.

13. The device of claim 1, wherein the device is a handle or a base that is operably coupleable to a single use medical device module configured for use within a body of a subject receiving a medical procedure.

14. The device of claim 1, wherein the device is a single use medical device is configured for use within a body of a subject receiving a medical procedure.

15. An endoscope comprising a single-use portion configured for insertion into a patient and a reusable portion to which the single-use portion is detachably attached to form said endoscope, comprising:

electronic components that are in said single-use portion of the endoscope and are configured to image a field of view in a patient while the single use portion is being used in a patient procedure; and

a self-sacrificing module (SSM) that is in said single-use portion of the endoscope and is configured to respond to an attempt to sterilize the single use portion after use thereof in a patient procedure by automatically preventing operation of said electronic components to thereby render the single-use portion unusable for a patient procedure;

wherein said SSM comprises a clock line configured to supply clock pulses to said electronic components and a switch responsive to said attempt to sterilize to disable said clock line and thereby deprive said electronic components of said clock pulses and make the electronic components non-functional.

16. The endoscope of claim 15, in which said SSM comprises a conduit supplying operating power to said electronic components and the switch responsive to said attempt to sterilize to disable said conduit and thereby deprive said electronic components of said operating power and make them nonfunctional.

17. The endoscope of claim 15, in which said attempt to sterilize comprises subjecting the single-use portion to sterilization by ionizing radiation.

18. The endoscope of claim 15, in which said attempt to sterilize comprises subjecting the single-use portion to sterilization by fluid.

19. The endoscope of claim 15, in which said attempt to sterilize comprises subjecting the single-use portion to sterilization by heat.

20. The endoscope of claim 15, in which said attempt to sterilize comprises subjecting the single-use portion to sterilization by ethylene oxide.

21. The endoscope of claim 15, in which said SSM is further configured to respond to a second attempt to sterilize said single-use portion but not to a first attempt to sterilize.

22. A method of using an endoscope made of a single-use portion configured for insertion into a patient and a reusable portion to which the single-use portion is detachably attached to form said endoscope, said method comprising:

introducing said single-use portion into a patient and imaging a field of view in the patient during a medical procedure using electronic components in said single-use portion; and

causing a self-sacrificing module (SSM) in said single-use portion to automatically respond to an attempt to sterilize the single use portion after use thereof in said medical procedure by automatically preventing operation of said electronic components to thereby render the single-use portion unusable for a patient procedure;

wherein said SSM comprises a clock line configured to supply clock pulses to said electronic components and a switch responsive to said attempt to sterilize to disable said clock line and thereby deprive said electronic components of said clock pulses and make the electronic components non-functional.