IP Library Granted Patent US 11,715,558
Granted Patent B2
US 11,715,558 · App. 16/912,337 · Granted Aug 1, 2023

Systems and methods for detecting defects in medical devices

Inventors: Salmaan Hameed (San Jose, CA); Stephen Budill (San Francisco, CA); Michael S. Humason (Newbury Park, CA)
Assignee: BH2 INNOVATIONS INC.
G16H40/40A61B1/00013A61B1/00029A61B1/00147A61B1/045G16H40/63A61B1/000096
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Quick Facts
Patent No.
US 11,715,558
App. No.
16/912,337
Granted
Aug 1, 2023
Kind
B2
Abstract

A detection system is adapted to perform methods for detecting defects in medical devices, during a reprocessing procedure, for example. The detection system may utilize computer-implemented instructions to determine the presence and nature of the defects, whether biological or mechanical, for example. The computer-implemented instructions may be adapted to include artificial intelligence and/or machine learning algorithms, and to process image data from digital inspection camera systems or proprietary camera systems. Upon identification of a defect present in a medical device, the detection system may notify users of the presence of the defect, as well as provide further recommended action to be taken regarding the medical device, if desirable, reducing potential instrument failure, patient injury or death. The disclosed detection system may be integrated into existing disinfection and sterilization systems currently used in medical facilities, such as hospitals and surgery centers, for example.

Claims (64)

1. A method for detecting defects of a medical device, the method comprising:

analyzing, based on operation of one or more processors of a detection system, a plurality of images;

detecting, by the operation of the one or more processors of the detection system, a plurality of different defects comprising one or more liquids, biological debris, non-biological debris, contaminants, and mechanical defects in the plurality of images using an artificial intelligence technique in conjunction with said analyzing;

positioning a detection scope within the medical device;

acquiring one or more images at a current location of the detection scope;

detecting, by the operation of the one or more processors of the detection system, one or more of the plurality of different defects within the medical device using the artificial intelligence technique, wherein detecting the one or more defects comprises:

determining the one or more defects to be a particular liquid, biological debris, non-biological debris, contaminant, or mechanical defect based on said analyzing;

obtaining first data comprising a record of one or more issues experienced by a plurality of patients after undergoing a procedure that involved the medical device;

obtaining second data comprising a service history of the medical device; and

selecting the medical device for reprocessing, removal from service, or a next procedure based on the first data, the second data, and the one or more defects.

2. The method of claim 1 , wherein said positioning of the detection scope comprises:

positioning the detection scope within a working channel of the medical device.

3. The method of claim 2 , further comprising:

determining whether an end of the working channel of the medical device has been reached;

advancing the detection scope;

repeating steps of acquiring the one or more images, detecting the one or more of the plurality of defects, and determining whether the end of the working channel of the medical device has been reached; and

updating procedural data after the end of the working channel of the medical device has been reached.

4. The method of claim 1 , wherein said detecting the one or more defects comprises:

determining a location for each of the one or more defects.

5. The method of claim 4 , wherein said determining the location for each of the one or more defects comprises:

performing an optical flow analysis.

6. The method of claim 4 , wherein said determining the location for each of the one or more defects comprises:

measuring an acceleration of a distal tip of the detection scope.

7. The method of claim 4 , wherein said determining the location for each of the one or more defects comprises:

measuring a ratio between a rotational movement of a motor and a linear movement of the detection scope.

8. The method of claim 1 , further comprising:

calculating a remaining useful life of the medical device based on the first data, the second data, and the one or more defects; and

removing the medical device from service based on the remaining useful life.

9. The method of claim 1 , further comprising:

tracking usage of the medical device in different medical procedures by different personnel;

identifying a plurality of future procedures scheduled by different personnel; and

scheduling use of the medical device by a particular personnel in at least one of the plurality of future procedures based on the usage and said tracking.

10. The method of claim 1 , further comprising:

determining historic usage of the medical device as part of a particular medical procedure from one or more of the first data, the second data, or third data;

scheduling use of the medical device to an upcoming instance of the particular medical procedure based on the historic usage.

11. The method of claim 1 , further comprising:

determining a current state of the medical device based on the one or more defects;

tracking historical usage and maintenance associated with the medical device as part of one or more of the first data and the second data; and

determining a remaining useful life for the medical device based on the current state and the historical usage and maintenance.

12. The method of claim 1 , wherein said detecting the one or more defects further comprises:

presenting a visual border around one or more regions in the one or more images with the one or more defects.

13. The method of claim 12 , wherein said detecting the one or more detects comprises:

presenting a textual identifier adjacent to the visual border, wherein the textual identifier comprises a value associated with the one or more defects within the visual border.

14. The method of claim 1 , further comprising:

tracking an extension of the detection scope through the medical device;

associating each image of the one or more images to a different position within the medical device based on a time each image is taken and the extension of the detection scope at the time each image is taken; and

providing a specific location of each of the one or more defects within the medical device based said associating.

15. The method of claim 1 , further comprising:

activating an optical fiber of the detection scope; and

illuminating a lumen within the medical device with the optical fiber as part of said acquiring the one or more images.

16. A device, comprising:

an imaging device configured to acquire image data; and

a processor coupled to the imaging device, the processor configured to:

analyze a plurality of images;

detect a plurality of different defects comprising one or more liquids, biological debris, non-biological debris, contaminants, and mechanical defects in the plurality of images using an artificial intelligence technique in conjunction with said analyzing;

track a position of the imaging device within a medical instrument;

acquire one or more images from the imaging device at different locations within the medical instrument;

detect one or more of the plurality of different defects within the medical instrument using the artificial intelligence technique, wherein detecting the one or more defects comprises:

determining the one or more defects to be a particular liquid, biological debris, non-biological debris, contaminant, or mechanical defect based on said analyzing;

obtain first data comprising a record of one or more issues experienced by a plurality of patients after undergoing a procedure that involved the medical instrument;

obtain second data comprising a service history of the medical instrument; and

select the medical instrument for reprocessing, removal from service, or a next procedure based on the first data, the second data, and the one or more defects.

17. The device of claim 16 , wherein the imaging device comprises:

one or more optical fibers extending to a distal end of the imaging device, wherein the one or more optical fibers are configured to illuminate an inner structure of the medical instrument as part of said acquiring the one or more images.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 22, 2023
From: HAMEED, SALMAAN; BUDILL, STEPHEN; HUMASON, MICHAEL S
To: BH2 INNOVATIONS INC.
Reel/Frame 063717/0259 →
Continuity (2)
Provisional Application 62866535 · Jun 25, 2019
Related Publication 20200405134A1 · Dec 31, 2020
Cited By (2)
US 12,394,518 US 12,580,077