Methods for Cryptographic Identification of Interchangeable Parts for Surgical Instruments

• US 20100230465A1
• Filed: 05/12/2010
• Published: 09/16/2010
• Est. Priority Date: 05/19/2006
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Palmer, Matthew A., Smith, Kevin W., Bales, Thomas O. JR., Deville, Derek Dee, Rivera, Carlos
• Granted Patent: US 9,439,651 B2
• Time in Patent Office: Days
• US Class Current: 227/176.100
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/07257 characterised by its anvil
• CPC Class Codes: A61B 2017/07271 characterised by its cartridge
• CPC Class Codes: A61B 2017/07285 characterised by its cutter
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: H04L 9/10 with particular housing, physical features or manual controls

Abstract

A method for encrypted authentication of interchangeable parts of a surgical instrument includes providing a surgical end effector at a distal end of a handle of the surgical instrument and electrically connecting an authentication controller within the handle to a receiving portion of the end effector. An interchangeable part is removably placed at the receiving portion. The interchangeable part is authenticated with the authentication controller when the interchangeable part is seated in the end effector.

Claims

1. 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; and

authenticating the interchangeable part with the authentication controller when the interchangeable part is seated in the end effector.

2. The method according to claim 1, which further comprises:

providing a first encrypted communication device at the interchangeable part; and

electrically connecting the first encrypted communication device to the authentication controller when the interchangeable part is seated in the end effector.

3. The method according to claim 2, which further comprises detecting when the interchangeable part is seated in the end effector with the authentication controller.

4. The method according to claim 3, 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.

5. The method according to claim 4, which further comprises:

providing a second encrypted communication device at the authentication controller; and

carrying out the automatic authentication by executing an encrypted authentication algorithm with the first and second communication devices.

6. The method according to claim 5, wherein the first and second communication devices are 1-wire devices.

7. The method according to claim 5, 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 1, 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 1, 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 1, 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 2, 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 2, 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.

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

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

22. The method according to claim 1, wherein the end effector and handle comprise one of a circular surgical stapler and a linear surgical stapler.

23. The method according to claim 5, 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 mm².

24. 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 a 1-wire encrypted authentication controller disposed within the surgical instrument handle to a receiving portion of the surgical end effector;

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

removably securing the interchangeable part at the receiving portion to electrically connect the 1-wire encrypted authentication controller to the 1-wire encrypted communication device and, thereby, authenticate the interchangeable part with the 1-wired encrypted authentication controller.

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

providing an interchangeable part with an 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;

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

authenticating the interchangeable part with at least the controller.