Serialization of single-use endoscopes

• US 10,226,163 B2
• Filed: 11/30/2015
• Issued: 03/12/2019
• Est. Priority Date: 05/18/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Couvillon, Jr., Lucien Alfred
• Primary Examiner(s): Leubecker, John P
• Application Number:
  US14/954,592
• Publication Number:
  US 20160081533A1
• Time in Patent Office: 1,198 Days
• CPC Class Codes: A61B 1/00006 of control signals
• CPC Class Codes: A61B 1/0002 provided with data storages
• CPC Class Codes: A61B 1/00057 provided with means for testing or calibration
• CPC Class Codes: A61B 1/00059 provided with identification means for the endoscope
• CPC Class Codes: A61B 1/00062 provided with means for preventing overuse
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 1/00121 Connectors, fasteners and adapters, e.g. on the endoscope handle
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/051 Details of CCD assembly
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: G06T 2207/10068 Endoscopic image
• CPC Class Codes: G06T 2207/30208 Marker matrix
• CPC Class Codes: G06T 7/80 Analysis of captured images to determine intrinsic or extrinsic camera parameters, i.e. camera calibration
• CPC Class Codes: H04N 1/0018 of images captured using a loaned, rented or limited-use still digital camera, e.g. recyclable or disposable camera
• CPC Class Codes: H04N 2201/3205 of identification information, e.g. name or ID code H04N2201/3209 takes precedence
• CPC Class Codes: H04N 7/183 for receiving images from a single remote source

Abstract

A system, device and method for serializing and authorizing a single use imaging device are provided. In one embodiment, the invention provides a single use imaging device comprising a memory having a stored code that includes a unique serial identifier. In another embodiment, the invention provides a system for authorizing a single use imaging device comprising a single use imaging device with an image of a verification object that includes a serial identifier uniquely associated with the device, a control unit capable of electronically receiving the verification object image, a decoder capable of extracting a serial identifier from the verification object image, a database of authorized serial identifiers, and means for determining if the single use imaging device is authorized.

Claims

1. A method of authorizing use of an imaging assembly coupled to an endoscopic device, the method comprising:

receiving, at a controller coupled to the imaging assembly, authorization data relating to an ability to use the imaging assembly stored in a memory coupled to the imaging assembly, wherein the endoscopic device also includes;

a connector coupling the imaging assembly to the controller;

a shaft extending from a proximal end to a distal end; and

an articulation joint at the distal end of the shaft, the articulation joint being configured to bend the distal end of the shaft at least 180 degrees,

wherein the imaging assembly is disposed at the distal end of the shaft, the imaging assembly being configured to transmit image signals to the controller, the image signals including;

one or more signals indicative of an image of an object in a field of view of the imaging assembly, wherein the image is defined by light reflected from the object, and

one or more signals indicative of an image of a verification object, wherein the one or more signals indicative of the image of the verification object are contained in the authorization data, and wherein the image of the verification object is defined by light reflected by the verification object;

comparing the authorization data received from the memory to a set of rules relating to whether the imaging assembly may be operated, wherein the authorization data is configured to enable only one use of the imaging assembly such that a subsequent attempt to operate the imaging assembly with any controller is prohibited;

permitting the imaging assembly to capture images and transmit image signals indicative of the captured images to the controller, if the comparison validates the authorization data;

tracking a usage of the imaging assembly if the comparison validates the authorization data;

preventing the imaging assembly from capturing images or transmitting image signals indicative of the captured images to the controller if the comparison does not validate the authorization data; and

providing a message to a user of the imaging assembly if the comparison does not validate the authorization data.

2. The method of claim 1, wherein the authorization data includes identification information that is unique to a given imaging assembly.

3. The method of claim 1, further including receiving the set of rules from a remote location over a network.

4. The method of claim 3, further including sending instructions to the remote location, over the network, to update the set of rules after use of the imaging assembly.

5. The method of claim 1, wherein the set of rules are stored locally in a memory of the controller.

6. The method of claim 1, wherein the authorization data includes one or more signals indicative of the image of the verification object, and wherein the method includes receiving reflected light with the imaging assembly, the reflected light being light reflected by the verification object.

7. The method of claim 1, wherein the imaging assembly includes a CMOS sensor.

8. A method of authorizing use of an imaging assembly coupled to an endoscopic device, the method comprising:

receiving authorization data, at least a part of which is indicative of light reflected by a verification object, in a circuit board of the imaging assembly;

sending the authorization data from the circuit board, in the format of an image signal, to a control unit coupled to the imaging assembly;

processing the authorization data with an image processor of the control unit;

comparing the authorization data to a set of rules relating to whether the imaging assembly may be operated;

permitting use of the imaging assembly with the control unit if the comparison validates the authorization data; and

prohibiting use of the imaging assembly with the control unit if the comparison does not validate the authorization data.

9. The method of claim 8, wherein prohibiting the use of the imaging assembly includes preventing the imaging assembly from capturing images or transmitting captured images to the controller.

10. The method of claim 8, wherein the endoscopic device comprises:

a connector coupling the endoscopic device to the controller; and

a shaft extending from a proximal end to a distal end.

11. The method of claim 10, wherein the imaging assembly is disposed at the distal end of the shaft, and is configured to transmit captured image signals to the controller, and wherein the method further includes receiving light, reflected by the verification object, at the imaging assembly.

12. The method of claim 8, wherein the authorization data is configured to enable only one use of the imaging assembly with any controller such that a subsequent attempt to operate the imaging assembly is prohibited.

13. The method of claim 8, further including tracking a usage of the imaging assembly if the comparison validates the authorization data.

14. The method of claim 8, further including providing a message to a user of the imaging assembly if the comparison does not validate the authorization data.

15. A method of authorizing use of an imaging assembly, the method comprising:

receiving light reflected by a verification object, wherein the light is received by the imaging assembly, and wherein the imaging assembly generates authorization data based on the received reflected light;

transmitting the authorization data from a circuit of the imaging assembly through an elongate member of a medical device to a remote processor connected to the imaging assembly, wherein the elongate member is adapted for insertion into an orifice of a body, wherein the authorization data includes a code, wherein the imaging assembly includes an image sensor and a memory for storing the code, wherein the code is associated with the imaging assembly and only one imaging assembly is associated with the code;

receiving, at the circuit, verification instructions from the remote processor that relate to verification of the code;

maintaining an image sensor of the imaging assembly in a deactivated state until the verification instructions from the remote processor verifies the code; and

permitting the imaging assembly to capture images or transmit captured images only when the remote processor verifies the code;

wherein the image sensor produces images in a predefined format, and the circuit transmits the authorization data in the same predefined format as the images.

16. The method of claim 15, further including inserting the elongate member into a subject, wherein the verification object remains outside the subject while the elongate member is within the subject.

17. The method of claim 15, wherein the remote processor extracts the code from the authorization data.

18. The method of claim 15, wherein the code encodes a serial identifier configured to authorize use of the imaging assembly.

19. The method of claim 15, wherein the code is one of a valid code or an invalid code.