Serialization of single use endoscopes

• US 9,230,324 B2
• Filed: 11/29/2007
• Issued: 01/05/2016
• Est. Priority Date: 05/18/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Couvillon, Lucien Alfred Jr.
• Primary Examiner(s): Leubecker, John P
• Application Number:
  US11/947,740
• Publication Number:
  US 20080076967A1
• Time in Patent Office: 2,959 Days
• Field of Search: 600/117, 600/118, 600/109, 348/72, 348/74, 382/181
• US Class Current: 1/1
• 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 medical imaging device, comprising:

a shaft adapted for insertion into an orifice of a body;

an image sensor associated with the shaft, wherein the image sensor produces images of tissue;

a memory in which a verification object is stored that uniquely identifies the medical imaging device, wherein the verification object includes one or more images of calibration objects; and

a circuit that transmits the verification object to a remote processor,

wherein the verification object is associated with only one medical imaging device, the medical imaging device is associated with only one verification object, the circuit is programmed to receive verification instructions from the remote processor and that relate to the verification object, and maintain the image sensor in a deactivated state until the verification instructions indicate a valid verification object.

2. The medical imaging device of claim 1, wherein the shaft has a distal end and a proximal end, and the image sensor is positioned at or adjacent the distal end of the shaft.

3. The medical imaging device of claim 1, wherein the verification object includes an image of a serial identifier, and the serial identifier is one of a linear barcode or a two-dimensional barcode.

4. The medical imaging device of claim 1, wherein the verification object is pre-stored in the memory.

5. The medical imaging device of claim 1, wherein the verification object is printed on a test target that is imaged by the image sensor.

6. The medical imaging device of claim 1, wherein the memory is integrated with the imaging sensor.

7. The medical imaging device of claim 1, wherein the circuit is configured to electronically retrieve the verification object via a network connection.

8. A medical device comprising:

an elongate member adapted for insertion into an orifice of a body;

an image sensor disposed adjacent a distal end of the elongate member, wherein the image sensor produces images of tissue;

a memory associated with the image sensor storing a code, wherein only one code is associated with the medical device, and only one medical device is associated with the code; and

a circuit that transmits the code to a remote processor, is programmed to receive verification instructions from the remote processor and that relate to verification of the code, and maintain the image sensor in a deactivated state until the remote processor verifies the code, wherein the image sensor produces images in a predefined format, and the circuit transmits the code in the same predefined format as the images produced by the image sensor.

9. The medical device of claim 8, wherein the code encodes a serial identifier configured to authorize use of the medical device.

10. The medical device of claim 8, wherein the memory is integrated with the image sensor.

11. The medical device of claim 8, wherein the memory is disposed adjacent a proximal end of the elongate member.

12. The medial device of claim 8, wherein the code is one of a valid code or an invalid code, and the image sensor is capable of producing images of tissue only if the remote processor verifies that the code is a valid code.

13. A medical imaging system comprising:

a medical device adapted to be inserted into an orifice of a body;

an image sensor adjacent a distal end of the medical device;

a serial identifier associated with the medical device, wherein only one serial identifier is associated with the medical device, and only one medical device is associated with the serial identifier, and wherein the image sensor stores a signal containing the serial identifier;

a calibration standard associated with the medical device, wherein the image sensor stores a signal containing the calibration standard; and

a transmit circuit that transmits the signal containing the serial identifier and the signal containing the calibration standard to a control unit, the control unit being configured to authorize the device and permit calibration of a functional aspect of the medical device;

wherein the transmit circuit is programmed to receive verification instructions from the control unit and that relate to the authorization of the medical device, and maintain the image sensor in a deactivated state until the verification instructions indicate a valid verification of the serial identifier, wherein the signal includes an image of the serial identifier.

14. The system of claim 13, wherein the medical device includes memory and wherein the serial identifier is stored in the memory of the device.

15. The system of claim 13, wherein the control unit includes a device capable of receiving the signal containing the serial identifier and the signal containing the calibration standard.

16. The system of claim 13, wherein the control unit includes a processor that determines if the device is authorized based upon the serial identifier associated with the device.

17. The system of claim 16, wherein the processor compares the serial identifier to a registry contained in a remote database accessible from the control unit.