System and method for preventing reprocessing of a powered surgical instrument

• US 10,383,629 B2
• Filed: 06/08/2010
• Issued: 08/20/2019
• Est. Priority Date: 08/10/2009
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ross, Adam, Zemlok, Michael
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Pahakis, Manolis
• Application Number:
  US12/796,194
• Publication Number:
  US 20110034910A1
• Time in Patent Office: 3,360 Days
• Field of Search: None
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A surgical instrument is disclosed. The instrument includes a microcontroller coupled to a memory, the microcontroller is configured to control the surgical instrument and a usage counter stored in the memory that is incremented when the surgical instrument is activated, wherein the microcontroller is further configured to prevent actuation of the surgical instrument when the usage counter is above a predetermined threshold.

Claims

1. A surgical instrument, comprising:

a housing;

an endoscopic portion extending distally from the housing;

an end effector coupled to the endoscopic portion;

at least one motor disposed within the housing and including a motor microcontroller having stored thereon a unique identifier associated with the at least one motor;

a memory device;

an instrument microcontroller coupled to the memory device and configured to control the surgical instrument, the instrument microcontroller configured to send a challenge request to the motor microcontroller of the at least one motor to authenticate the at least one motor by comparing the unique identifier associated with the motor microcontroller of the at least one motor with a pre-approved set of identifiers;

a sterilization counter stored in the memory device, and

a sterilization sensor coupled to the instrument microcontroller, the instrument microcontroller configured to increment the sterilization counter when the sterilization sensor detects at least one of temperature or moisture above a predetermined threshold,

wherein the unique identifier is a unique electrical, measurable value of the motor, the electrical, measurable value of the motor including a resistance, a capacitance, an inductance, or combinations thereof.

2. The surgical instrument according to claim 1, further comprising:

a usage counter stored in the memory device and configured to be incremented in response to activation of the surgical instrument.

3. The surgical instrument according to claim 2, wherein the memory device includes a device status word that incorporates the usage counter, the sterilization counter and an authentication flag, the authentication flag configured to be activated based on a predetermined identifier.

4. The surgical instrument according to claim 3, wherein the device status word is encrypted.

5. The surgical instrument according to claim 3, wherein the instrument microcontroller is further configured to prevent actuation of the surgical instrument in response to at least one of the usage counter being above a predetermined threshold, the sterilization counter being above a predetermined threshold, or the authentication flag being activated.

6. The surgical instrument according to claim 1, wherein the surgical instrument is a surgical stapling instrument and the end effector includes an anvil assembly and a cartridge assembly, wherein the instrument microcontroller is electrically coupled to the motor.

7. The surgical instrument according to claim 6, wherein the motor is configured to cause the cartridge assembly and the anvil assembly to clamp together.

8. The surgical instrument according to claim 7, further comprising a usage counter stored in the memory device, wherein the usage counter is configured to be incremented when the motor is activated.

9. The surgical instrument according to claim 1, further comprising a loading unit including a body portion extending distally from the endoscopic portion, wherein the end effector is pivotably attached to the body portion.

10. The surgical instrument according to claim 9, wherein the loading unit includes a loading unit microcontroller.

11. The surgical instrument according to claim 1, wherein the motor microcontroller of the at least one motor is coupled to the instrument microcontroller through a wireless communication protocol.

12. The surgical instrument according to claim 1, wherein the housing includes a handle portion having a main drive switch configured to activate the motor.

13. The surgical instrument according to claim 1, wherein the sterilization sensor partially extends through an outer wall of the housing.

14. The surgical instrument according to claim 13, wherein the sterilization sensor includes a temperature sensor and a moisture sensor.