Apparatus for counting the number of times a surgical instrument has been used

• US 5,313,935 A
• Filed: 08/17/1993
• Issued: 05/24/1994
• Est. Priority Date: 12/31/1992
• Status: Expired due to Fees

• Current Assignee: Symbiosis Corporation (Boston Scientific Corporation)
• Original Assignee: Symbiosis Corporation (Boston Scientific Corporation)
• Inventors: Slater, Charles R., Kortenbach, Jurgen A., Nunez, George
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): FLANAGAN, BEVERLY MEINDL
• Application Number:
  US08/107,456
• Time in Patent Office: 280 Days
• Field of Search: 116/206, 116/207, 116/216, 116/221, 116/284, 235/131 JA, 235/139 A, 235/142, 235/144 ME, 128/4, 606/205
• US Class Current: 600/117
• CPC Class Codes: A61B 1/00055 for alerting the user
• CPC Class Codes: A61B 1/00062 provided with means for preventing overuse
• CPC Class Codes: A61B 1/00105 characterised by modular construction
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/292 connection of actuating rod to handle, e.g. ball end in recess
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/1412 Blade
• CPC Class Codes: A61B 2018/1415 multiple blades
• CPC Class Codes: A61B 2018/1455 having a moving blade for cutting tissue grasped by the jaws
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: G06M 1/041 for drum-type indicating means
• CPC Class Codes: G06M 3/12 for preventing incorrect actuation, e.g. for preventing falsification

Abstract

An improved use counter for endoscopic instruments is mounted in the ferrule of the distal portion of an endoscopic instrument having separable proximal and distal portions. The counter includes a ratchet wheel having inner and outer teeth and a bimetallic coil having a fixed end and a free end. The fixed end of the bimetallic coil is attached to a hub portion of the ferrule and the free end of the bimetallic coil engages the inner teeth of the ratchet wheel. An inwardly extending tooth in the ferrule engages the outer teeth of the ratchet wheel to prevent backward movement of the ratchet wheel. The outer surface of the ratchet wheel is also provided with incremental indicia viewable through a window in the ferrule. As the bimetallic coil is heated and cooled when the instrument is sterilized, the free end of the coil engages and advances one tooth of the ratchet wheel. Movement of the free end is preferably limited by stops. A spring biased locking and disabling pin is mounted in the ferrule and engages a stepped width portion of the ratchet wheel. The pin prevents advancement of the ratchet wheel during shipping and disables the instrument after a predetermined number of sterilizations.

Claims

1. An apparatus for counting the number of times a surgical instrument has been sterilized, said apparatus comprising:

a) a housing having an inner hub portion and an outer cylindrical portion, said outer cylindrical portion having an inwardly extending tooth and an indication means;

b) a ratchet wheel having a plurality of inner teeth, a plurality of outer teeth, and outer incremental indicia, said ratchet wheel being located between said inner hub portion and said outer cylindrical portion of said housing such that one of said plurality of outer teeth is engaged by said inward extending tooth and one of said incremental indicia is indicated by said indication means; and

c) a bimetallic member having a free end and a fixed end, said free end engaging one of said plurality of inner teeth and said fixed end being attached to said inner hub portion of said housing, wherein

a sterilization heating and cooling cycle causes said bimetallic member to engage a next one of said inner teeth and to advance said ratchet wheel past said inward extending tooth so that a next one of said incremental indicia is indicated by said indication means, and said inward extending tooth prevents said ratchet wheel from returning to a previous position.

2. An apparatus according to claim 1, wherein:

said inwardly extending tooth of said housing is a ramped tooth with a shoulder, and said plurality of inner teeth and plurality of outer teeth of said ratchet wheel are ramped teeth having shoulders.

3. An apparatus according to claim 1, wherein:

said bimetallic member is a coil.

4. An apparatus according to claim 1, wherein:

said plurality of inner teeth include a first tooth and a last tooth with a toothless space between said first and last tooth so that upon advancing said ratchet wheel to a last position it may not be advanced further.

5. An apparatus according to claim 1, further comprising:

d) stop means adjacent said free end of said bimetallic member for limiting movement of said free end.

6. An apparatus according to claim 5, wherein:

said stop means includes a post extending from said housing, and said free end of said bimetallic member includes a notch within which said post extends.

7. An apparatus according to claim 1, further comprising:

d) disengageable locking means engaging said ratchet wheel for preventing advancement of said ratchet wheel by said bimetallic coil member.

8. An apparatus according to claim 7, wherein:

said locking means comprises a spring biased pin and said ratchet wheel includes a notch engageable by said pin.

9. An apparatus according to claim 8, wherein:

said spring biased pin is held in a position engaging said notch by disengagable means attached to a package containing the surgical instrument so that when the surgical instrument is removed from the package, said disengagable means is removed from said spring biased pin and said pin is biased out of engagement with said notch.

10. An apparatus according to claim 1, wherein:

the surgical instrument has separable proximal and distal portions, the proximal portion of the surgical instrument having first coupling means for removably coupling with the distal portion of the surgical instrument and the distal portion of the instrument having second coupling means for removably coupling with the proximal portion of the instrument, and said apparatus further comprises,

d) disabling means for preventing the proximal and distal portions of the surgical instrument from coupling after said ratchet wheel has been advanced to a predetermined position.

11. An apparatus according to claim 10, wherein:

said housing comprises a ferrule on the distal portion of said surgical instrument,

said disabling means includes a spring biased pin mounted in the ferrule and biased out of the ferrule,

said spring biased pin is pressed into said ferrule by said first coupling means when the proximal and distal portions of the surgical instrument are coupled, and

said ratchet wheel has a narrow width portion engageable by said pin when said pin is pressed into the ferrule and a wide width portion which prevents said pin from being pressed into the ferrule.

12. An apparatus according to claim 5, further comprising:

e) disengageable locking means engaging said ratchet wheel for preventing advancement of said ratchet wheel by said bimetallic coil member.

13. An apparatus according to claim 12, wherein:

said locking means comprises a spring biased pin and said ratchet wheel includes a notch engageable by said pin, and

said spring biased pin is held in a position engaging said notch by disengagable means attached to a package containing the surgical instrument so that when the surgical instrument is removed from the package, said disengagable means is removed from said spring biased pin and said pin is biased out of engagement with said notch.

14. An apparatus according to claim 5, wherein:

the surgical instrument has separable proximal and distal portions, the proximal portion of the surgical instrument having first coupling means for removably coupling with the distal portion of the surgical instrument and the distal portion of the instrument having second coupling means for removably coupling with the proximal portion of the instrument, and said apparatus further comprises,

e) disabling means for preventing the proximal and distal portions of the surgical instrument from coupling after said ratchet wheel has been advanced to a predetermined position.

15. An apparatus according to claim 14, wherein:

said housing comprises a ferrule on the distal portion of said surgical instrument,

said disabling means includes a spring biased pin mounted in the ferrule and biased out of the ferrule,

said spring biased pin is pressed into said ferrule by said first coupling means when the proximal and distal portions of the surgical instrument are coupled, and

said ratchet wheel has a narrow width portion engageable by said pin when said pin is pressed into the ferrule and a wide width portion which prevents said pin from being pressed into the ferrule.

16. An apparatus according to claim 12, wherein:

the surgical instrument has separable proximal and distal portions, the proximal portion of the surgical instruments having first coupling means for removably coupling with the distal portion of the surgical instrument and the distal portion of the instrument having second coupling means for removably coupling with the proximal portion of the instrument, and said apparatus further comprises,

f) disabling means for preventing the proximal and distal portions of the surgical instrument from coupling after said ratchet wheel has been advanced to a predetermined position.

17. An apparatus according to claim 16, wherein:

said housing comprises a ferrule on the distal portion of said surgical instrument,

said disabling means includes a spring biased pin mounted in the ferrule and biased out of the ferrule,

said spring biased pin is pressed into said ferrule by said first coupling means when the proximal and distal portions of the surgical instrument are coupled, and

said ratchet wheel has a narrow width portion engageable by said pin when said pin is pressed into the ferrule and a wide width portion which prevents said pin from being pressed into the ferrule.

18. An apparatus according to claim 16, wherein:

said bimetallic member is a coil, and

said plurality of inner teeth include a first tooth and a last tooth with a toothless space between said first and last tooth so that upon advancing said ratchet wheel to a last position it may not be advanced further.

19. An apparatus according to claim 18, wherein:

said inwardly extending tooth of said housing is a ramped tooth with a shoulder, and said plurality of inner teeth and plurality of outer teeth of said ratchet wheel are ramped teeth having shoulders.