Granted Patent B2

US 12,369,789 · App. 16/706,985 · Granted Jul 29, 2025

Inventors: Joshua D. Talbert (Cottonwood Heights, UT); Jeremiah D. Henley (Salt Lake City, UT); Donald M. Wichern (Ogden, UT)

Assignee: DePuy Synthes Products, Inc.

A61B1/3132A61B1/00006A61B1/00009A61B1/015A61B1/05

Abstract

Claims (60)

1. An imaging system for surgical use comprising:

a single-use imaging device comprising:

a handheld unit comprising memory and a processor, wherein the processor comprises decision making or logic processing capabilities regarding a condition of the single-use imaging device;

a lumen configured for use in a minimally invasive surgery;

an image sensor disposed within the lumen, wherein the image sensor is located near a tip of the lumen; and

an optical element disposed at the tip of the lumen;

a control unit separate from the single-use imaging device, wherein the control unit communicates with the single-use imaging device to exchange information with the single-use imaging device, and wherein the control unit comprises a control unit processor; and

an electronic communication circuit configured for providing electronic communication between the single-use imaging device and the control unit such that the single-use imaging device can be connected to and disconnected from the control unit;

wherein the control unit determines whether the single-use imaging device has been powered off for a time period based on data stored in the memory of the handheld unit; and

wherein the data stored in the memory of the handheld unit comprises a first measurement of time that the single-use imaging device was powered on, and a second measurement of time that the single-use imaging device spent powered off since being powered on at least once;

wherein the control unit analyzes the first measurement of time and the second measurement of time, and disables the single-use imaging device in response to determining the second measurement of time is outside a predetermined range.

2. The imaging system of claim 1 , wherein the data stored in the memory of the handheld unit pertains to the single-use imaging device, and wherein the data comprises one or more of:

data representing the number of hours of operation of the imaging device;

data representing the number of times the imaging device has been used;

data representing a unique identification code;

data representing a date of manufacture;

data representing a date of last verification/quality check;

data representing a location of manufacture;

data representing the last control unit to which the imaging device was connected;

data representing diagnostic information;

data representing procedural specific settings;

data representing a date of sterilization; or

data representing specific settings for a specific user.

3. The imaging system of claim 2 , wherein the processor of the control unit is configured to execute instructions stored in non-transitory computer readable storage medium, the instructions comprising:

checking the data pertaining to the single-use imaging device to determine a manufacturing date of the single-use imaging device, and

disabling functionality of the single-use imaging device in response to determining that the manufacturing date is outside a predetermined date range.

4. The imaging system of claim 2 , wherein the processor of the control unit is configured to execute instructions stored in non-transitory computer readable storage medium, the instructions comprising:

checking the data pertaining to the single-using imaging device to determine whether the single-use imaging device has been reclaimed, and

disabling functionality of the single-use imaging device in response to determining the single-use imaging device has been reclaimed.

5. The imaging system of claim 2 , wherein the processor of the control unit is configured to execute instructions stored in non-transitory computer readable storage medium, the instructions comprising:

checking the data pertaining to the single-use imaging device to determine if the imaging device has been reclaimed,

checking the data pertaining to the single-use imaging device to determine a reclamation date of the single-use imaging device, and

disabling functionality of the single-use imaging device in response to determining that the reclamation date is outside a predetermined date range.

6. The imaging system of claim 1 , wherein the data stored in the memory of the handheld unit further comprises a serial number for providing identification of the single-use imaging device.

7. The imaging system of claim 1 , further comprising a counting circuit that is configured to cause a count value to be recorded in the memory of the handheld unit each time the single-use imaging device is used.

8. The imaging system of claim 1 , further comprising a timing circuit configured to cause a date and time value to be recorded in the memory of the handheld unit when the single-use imaging device is powered on, and wherein the timing circuit further records a duration of time the single-use imaging device is in use.

9. The imaging system of claim 1 , further comprising:

a view optimizing assembly configured to deliver a fluid to a surface of the optical element, wherein the view optimizing assembly comprises:

a sheath sized and configured to receive the lumen;

a fluid flow channel within the sheath for directing a fluid toward the optical element;

an opening in the sheath sized for receiving the lumen therethrough;

a view opening in the sheath for providing the image sensor access to light.

10. The imaging system of claim 9 , wherein the fluid is supplied as part of an insufflator circuit.

11. The imaging system of claim 9 , wherein the fluid is one or more of saline or carbon dioxide.

12. The imaging system of claim 1 , wherein the single-use imaging device is sterilized and prepared for single use such that the control unit will one or more of:

disable functionality of the single-use imaging device if the single-use imaging device has been used; or

disable functionality of the single-use imaging device if the single-use imaging device has not been sterilized and reprocessed since a prior use.

13. The imaging system of claim 1 , wherein the optical element comprises one or more lenses.

14. The imaging system of claim 1 , wherein the control unit is a camera control unit comprising:

a light source for providing electromagnetic radiation to a distal tip of the lumen;

the control unit processor;

a time circuit;

a counting circuit; and

control unit memory

wherein the control unit is configured to be reused with a plurality of different single-use imaging devices.

15. The imaging system of claim 1 , wherein the control unit is configured to be reused with a plurality of different single-use imaging devices, and wherein processing resources for actuating the image sensor are offloaded to the control unit.

16. The imaging system of claim 9 , further comprising a locking mechanism that detachably locks the view optimizing assembly to the imaging device.

17. The imaging system of claim 9 , wherein the view optimizing assembly is sterilized and configured for single use.

18. The imaging device of claim 9 , wherein the sheath comprises a plurality of fluid flow channels.

19. The imaging device of claim 9 , wherein the image optimizing assembly further comprises a deflection assembly.

Assignments (2)

Continuity (3)

References Cited (24)