Post-sterilization programming of surgical instruments

• US 7,738,971 B2
• Filed: 01/10/2007
• Issued: 06/15/2010
• Est. Priority Date: 01/10/2007
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Shelton, Frederick E. IV, Swayze, Jeffrey S.
• Primary Examiner(s): Patel; Ramesh B
• Assistant Examiner(s): Sivanesan; Sivalingam
• Application Number:
  US11/651,771
• Publication Number:
  US 20080167736A1
• Time in Patent Office: 1,252 Days
• Field of Search: 700/1, 600/104, 600/118, 600/1, 600/46
• US Class Current: 700/1
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/00362 Packages or dispensers for MIS instruments A61B2017/0479 takes precedence
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• 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 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40

Abstract

A surgical instrument with a programmable control unit and methods for programming the control unit while the surgical instrument is in a sterile container. The method may comprise packaging the surgical instrument in the container and then sterilizing the surgical instrument while the surgical instrument is in the container. The method may further comprise programming the surgical instrument while the surgical instrument is in the container with a programming device positioned outside of the container.

Claims

1. A combination comprising:

a sterile container;

a surgical instrument inside the sterile container, the surgical instrument comprising;

a control unit, wherein the control unit comprises;

a processor; and

a non-volatile memory in communication with the processor;

an electric motor for actuating the surgical instrument when the surgical instrument is removed from the sterile container and operated by a user; and

a battery for supplying power to the electric motor when the surgical instrument is removed from the sterile container and operated by the user; and

a remote programming device, outside of the sterile container, for wirelessly transmitting, when the surgical instrument is inside the sterile container, programming code to the control unit for storage in the non-volatile memory, wherein the programming code stored in the non-volatile memory is executed by the processor when the surgical instrument is removed from the sterile container and operated by the user.

2. The combination of claim 1, wherein the control unit further comprises:

a power circuit for passively powering the control unit from wireless signals received from the remote programming device.

3. The combination of claim 2, wherein the memory further stores a boot loading sequence for execution by the processor.

4. The combination of claim 1, wherein the control unit and the remote programming device are inductively coupled.

5. The combination of claim 1, wherein the control unit and the remote programming device are capacitively coupled.

6. The combination of claim 1, wherein the surgical instrument comprises:

a handle housing the control unit;

a shaft connected to the handle; and

an end effector connected to the shaft.

7. The combination of claim 6, wherein the end effector comprises a cutting instrument.

8. The combination of claim 7, wherein the handle further comprises:

a motor in communication with the control unit; and

a battery for powering the motor.

9. The combination of claim 1, wherein the surgical instrument comprises an endoscopic surgical instrument.

10. A method comprising:

packaging a surgical instrument in a container;

sterilizing the surgical instrument while the surgical instrument is in the container; and

after sterilizing the surgical instrument, programming the surgical instrument while the surgical instrument is in the container with a programming device positioned outside of the container.

11. The method of claim 10, wherein programming the surgical instrument comprises wirelessly programming the surgical instrument with the programming device.

12. The method of claim 10, wherein the step of sterilizing the surgical instrument comprises subjecting the surgical instrument to radiation.

13. The method of claim 12, wherein the radiation comprises gamma radiation.

14. The method of claim 10, wherein the step of sterilizing the surgical instrument comprises subjecting the surgical instrument to ethylene oxide.

15. The method of claim 10, wherein the surgical instrument comprises a programmable control unit.

16. The method of claim 10, wherein:

the surgical instrument comprises an external connection interface;

the container comprises a connection interface that mates with the external connection interface when the surgical instrument is contained in the container; and

programming the instrument comprises connecting the programming device to the connection interface of the container.

17. A combination comprising:

a surgical instrument comprising a handle, wherein the handle comprises;

a control unit in the handle; and

an external connection interface for the control unit; and

a sterile container containing the surgical instrument, wherein the container comprises a connection interface that comprises an interior end that mates with the external connection interface of the surgical instrument and an exterior end at the exterior of the container.

18. The combination of claim 17, further comprising a programming device adapted for connection to the exterior end of the connection interface of the container.