Method and Apparatus for Medical Devices Under Regulatory Control

• US 20180253532A1
• Filed: 03/02/2017
• Published: 09/06/2018
• Est. Priority Date: 03/02/2017
• Status: Active Grant

• Current Assignee: Karl Storz Imaging, Inc (Karl Storz Se & Co. Kg)
• Original Assignee: Karl Storz Imaging, Inc (Karl Storz Se & Co. Kg)
• Inventors: Granneman, Russell
• Granted Patent: US 11,257,590 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/00006 of control signals
• CPC Class Codes: A61B 1/00059 provided with identification means for the endoscope
• CPC Class Codes: A61B 1/043 for fluorescence imaging
• CPC Class Codes: A61B 1/045 Control thereof
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Systems, devices, methods, and program products are provided for operating a medical system that is operable within at least two different medical device regulatory classes. A device control module receives an indicator for performing at least one procedure with a medical device. Based on the indicator, it selects a binary image for booting the control module from among multiple images including a controlled-type and a non-controlled type, which operate in different regulatory classes. A controlled-type image, which may be FDA PMA or other regulatory classes, is verified to be unaltered, and is then used to operate as a regulated medical device. The indicator can be automatic or manual. The indicator may result from connection of a specific medical device or peripheral device, or may be user input.

Claims

1. A method of operating a medical system that is operable within at least two different medical device regulatory classes, the at least two different regulatory classes including a first regulatory class and a second regulatory class, the method comprising:

receiving an indicator for performing at least one medical procedure that utilizes a medical device;

based on the indicator, selecting one of multiple binary images for booting a medical device control module, the multiple binary images including at least a controlled type binary image for operating as a first regulatory class medical device and a non-controlled type binary image for operating as a second regulatory class medical device; and

if the selected binary image is the controlled type binary image, booting the medical device control module from the controlled type binary image and thereby operating the medical device control module as the first regulatory class medical device for performing the at least one medical procedure.

2. The method of claim 1, wherein the first regulatory class medical device is of a class that requires FDA premarket approval and a second regulatory class medical device is of a class that does not require FDA premarket approval.

3. The method of claim 1, wherein the first regulatory class medical device is an FDA Class III medical device and the second regulatory class medical device is one of an FDA Class I and Class II device.

4. The method of claim 1, in which the medical device is a front end module for coupling an imaging scope to the medical device control module.

5. The method of any of claim 1, in which receiving the indictor further comprises recognizing that the medical device has been coupled to the medical device control module and obtaining a device identifier for the medical device.

6. The method of claim 1, further comprising

recognizing that a peripheral device has been coupled to the medical device control module;

obtaining a device identifier for the peripheral device;

wherein selecting one of multiple binary images is further based on the peripheral device identifier.

7. The method of claim 6, in which the peripheral device is a display module.

8. The method of claim 1, in which the medical procedure is an endoscopic fluorescence imaging procedure.

9. The method of claim 1, in which the medical device is a fluorescence imaging scope or a combination of a fluorescence imaging scope and a front end module for coupling the fluorescence imaging scope to the medical device control module.

10. The method of claim 1, further comprising installing an update for a selected one of the multiple binary images being the non-controlled type.

11. The method of claim 1, further comprising if the selected binary image is a non-controlled type binary image, booting the medical device control module from the non-controlled binary image and thereby operating the medical device control module as the second regulatory class medical device for performing the at least one medical procedure.

12. The method of claim 1, in which the multiple binary images include program code for a microprocessor and FPGA configuration code for configuring at least one FPGA in the medical device control module.

22. The medical device control module of claim 11, in which the program code further comprises update program code executable by the at least one digital processor to update a selected non-controlled binary image, and subsequently to recognize that a different medical device has been coupled to a medical device control module, obtain a device identifier for the different medical device, and based on the device identifier, select the updated binary image and then boot the medical device control module from the updated binary image.

13. A medical device control module, either integrated with a medical device or configured to connect to a medical device, that is operable within at least two different medical device regulatory classes, the at least two different regulatory classes including a first regulatory class and a second regulatory class, the module comprising:

at least one digital processor and associated RAM memory;

tangible non-transitory computer readable media containing;

(a) at least one binary image of a controlled type for operating as a device within the first regulatory class;

(b) at least one binary image of a non-controlled type for operating as a device within the second regulatory class;

(c) boot manager program code executable by the digital processor to

receive an indicator for performing at least one medical procedure that utilizes a medical device;

based on the indicator, select one of the binary images for booting the medical device control module;

determine if the selected binary image is a controlled type image, and if so, perform a verification of the image and then boot the medical device control module from the controlled type binary image; and

the at least one digital processor operable to, after booting from the controlled type binary image, execute program code from the controlled type binary image for operating the medical device control module, and controlling the medical device, as a first regulatory class medical device for performing the at least one medical procedure.

14. The medical device control module of claim 13, which the boot manager program code further includes program code executable by the at least one digital processor for (i) recognizing that a medical device has been coupled to a medical device control module;

(ii) obtaining a device identifier for the medical device; and

(iii) wherein selecting one of multiple binary images is further based on the peripheral device identifier.

15. The medical device control module of claim 13, in which the medical device is a front end module for coupling an imaging scope to the medical device control module.

16. The medical device control module of claim 13, in which the boot manager program code further comprises code executable by the at least one digital processor for recognizing that a peripheral device has been coupled to the medical device control module and obtaining a device identifier for the peripheral device, wherein selecting one of multiple binary images is further based on the peripheral device identifier.

17. The medical device control module of claim 16, in which the peripheral device is a display module.

18. The medical device control module of claim 13, wherein the first regulatory class medical device is of a class that requires FDA premarket approval and a second regulatory class medical device is of a class that does not require FDA premarket approval.

19. The medical device control module of claim 18, in which, the medical device is configured to conduct an endoscopic fluorescence imaging procedure.

20. The medical device control module of claim 13, in which the medical device is a fluorescence imaging scope or a combination of a fluorescence imaging scope and a front end module for coupling the fluorescence imaging scope to the medical device control module.

21. The medical device control module of claim 13, in which the multiple binary images include program code for a microprocessor and FPGA configuration code for configuring at least one FPGA in the medical device control module.

23. The medical device control module of claim 13, in which the program code further comprises controlled-update program code executable by the at least one digital processor to verify a replacement controlled binary image, remove a selected controlled binary image, and replace it with the replacement controlled binary image and subsequently to recognize that a different medical device has been coupled to a medical device control module, obtain a device identifier for the different medical device, and based on the device identifier, select the updated binary image and then boot the medical device control module from the updated binary image.

24. A method of operating a medical system that is operable within at least two different medical device regulatory classes, the at least two different regulatory classes including a first regulatory class and a second regulatory class, the method comprising:

receiving an indicator for performing at least one medical procedure that utilizes a medical device;

based on the indicator, selecting one of multiple binary images for operating a medical device control module, the multiple binary images including at least a controlled type binary image for a first regulatory class medical device and a non-controlled type binary image for a second regulatory class medical device; and

if the selected binary image is the controlled type binary image, exclusively operating the medical device control module via the controlled type binary image and thereby providing the medical device control module as a part of the first regulatory class medical device for performing the at least one medical procedure.