Methods for cryptographic identification of interchangeable parts for surgical instruments

1. A method for operating a surgical instrument, which comprises:

providing a surgical end effector at a distal end of a surgical instrument handle;

electrically connecting an authentication controller disposed within the surgical instrument handle to a receiving portion of the surgical end effector;

providing an interchangeable part with a first 1-wire encrypted communication device, the interchangeable part being shaped to removably secure at the receiving portion;

providing the authentication controller with a second 1-wire encrypted communication device; and

removably securing the interchangeable part at the receiving portion to electrically connect the authentication controller to the first 1-wire encrypted communication device and, thereby, authenticate the interchangeable part with the authentication controller by executing an encrypted authentication algorithm with the first and second communication devices.

2. A method for operating a surgical instrument, which comprises:

providing an interchangeable part with a first encrypted authentication device;

providing a handle with a distal surgical end effector having a receiving portion;

electrically connecting an authentication controller of the handle to a communication connection of the receiving portion, wherein the authentication controller is provided with a second encrypted authentication device;

removably placing the interchangeable part at the receiving portion to electrically connect the first encrypted authentication device to the authentication controller; and

authenticating the interchangeable part with at least the controller by executing an encrypted authentication algorithm with the first and second encrypted authentication devices.

3. A method for operating a surgical instrument, which comprises:

providing a surgical end effector at a distal end of a handle of the surgical instrument;

electrically connecting an authentication controller within the handle to a receiving portion of the end effector;

removably placing an interchangeable part at the receiving portion, wherein:

the interchangeable part is provided with a first encrypted communication device that is electrically connected to the authentication controller when the interchangeable part is seated in the end effector; and

the authentication controller is provided with a second encrypted communication device; and

authenticating the interchangeable part with the authentication controller when the interchangeable part is seated in the end effector by executing an encrypted authentication algorithm with the first and second communication devices.

4. The method according to claim 3 , which further comprises detecting when the interchangeable part is seated in the end effector with the authentication controller.

5. The method according to claim 4 , which further comprises automatically authenticating the interchangeable part with the authentication controller when the interchangeable part is detected as being seated in the end effector.

6. The method according to claim 3 , wherein the first and second communication devices are 1-wire devices.

7. The method according to claim 3 , which further comprises:

providing each of the first and second communication devices with a respective one of first and second secured memories; and

storing part-specific information in at least one of the first and second secured memories.

8. The method according to claim 7 , which further comprises:

providing an inventory of the interchangeable parts each with a respective first communication device; and

controlling use of the interchangeable parts with the surgical instrument by reading the part-specific information in the secured memory of the respective first communication device with the controller and, based upon the information, permitting or prohibiting use of the part.

9. The method according to claim 8 , wherein the part-specific information is a unique identifier distinguishing an interchangeable part from other interchangeable parts in the inventory.

10. The method according to claim 8 , which further comprises carrying out the controlling step by only permitting use of interchangeable parts from a predefined source.

11. The method according to claim 7 , which further comprises:

providing an inventory of the interchangeable parts each with a respective first communication device; and

controlling a use of the interchangeable parts with the surgical instrument by reading the part-specific information contained in the secured memory of the first communication device with the controller when the part is seated in the end effector and, based upon the part-specific information, carrying out one of a number of different uses for the surgical instrument.

12. The method according to claim 7 , which further comprises:

providing an inventory of the interchangeable parts each with a respective first communication device; and

controlling use of the interchangeable parts with the surgical instrument by reading the part-specific information contained in the secured memory of the first communication device with the controller and, based upon the information:

selecting at least one of a set of different procedures; and

executing the at least one selected procedure with the surgical instrument.

13. The method according to claim 7 , which further comprises:

providing an inventory of the interchangeable parts each with a respective first communication device;

providing an inventory of the surgical instruments each having the handle, the surgical end effector at the distal end of the handle, and the second communication device; and

controlling use of the interchangeable parts with the surgical instruments by reading the part-specific information in the secured memory of the first communication device with the controller of a given one of the handles and, based upon the information, permitting or prohibiting use of the part with the given one of the handles.

14. The method according to claim 3 , which further comprises:

after authenticating the interchangeable part, using the part with the end effector to effect a surgical procedure; and

after use, storing data within an authentication device of the part, the data being selected from at least one of the group consisting of:

an identity of the handle to which the part was connected;

an identity of the handle that used the part;

temporal data associated with the use of the part;

data reflecting the number of uses of the part; and

data reflecting an operational failure of the part.

15. The method according to claim 3 , which further comprises:

after authenticating the interchangeable part, using the part with the end effector to effect a surgical procedure; and

after use, storing data within an authentication device of the handle, the data being selected from at least one of the group consisting of:

an identity of the part that was connected to the handle;

temporal data associated with the use of the part;

physical data associated with the use of the part;

data reflecting the number of uses of the part; and

data reflecting an operational failure of the part.

16. The method according to claim 15 , which further comprises:

processing the stored data to carry out analyses selected from at least one of the group consisting of:

part failure rates;

user misuse rates; and

remedial user instruction.

17. The method according to claim 3 , which further comprises:

providing the handle with a removable power supply electrically connected to the controller; and

providing the removable power supply with an encrypted authentication device.

18. The method according to claim 3 , which further comprises:

providing the end effector with at least one sensor;

reading sensed data from the at least one sensor with the first encrypted communication device;

transmitting the data from the first encrypted communication device to the authentication controller; and

storing the data at the authentication controller.

19. The method according to claim 18 , wherein the at least one sensor is one of a temperature sensor and a pressure sensor.

20. The method according to claim 3 , which further comprises:

providing the handle with at least one sensor;

reading sensed data from the at least one sensor with the authentication controller; and

storing the data at the controller.

21. The method according to claim 20 , wherein the at least one sensor is one of a temperature sensor and a pressure sensor.

22. The method according to claim 3 , wherein the end effector and handle comprise one of a circular surgical stapler and a linear surgical stapler.

23. The method according to claim 3 , which further comprises:

providing the first and second encrypted communication devices each with a microprocessor; and

forming the first and second devices to have a circuit board footprint of less than 50 mm 2 .