# US 11,298,129 B2 · Method for providing an authentication lockout in a surgical stapler with a replaceable cartridge

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- Number: US 11,298,129 B2
- Document ID: US11298129B2
- Status: Granted
- Kind: B2
- Application number: 16/453,273
- Filed: 2019-06-26
- Published: 2020-08-20
- Granted: 2022-04-12
- Earliest claimed: 2019-02-19
- Assignees: Cilag GmbH International
- Applicants: Ethicon LLC
- Inventors: Gregory J. Bakos; Chad P. Boudreaux; Frederick E. Shelton, IV; Jason L. Harris; Richard W. Timm
- Web page: https://patentgrep.com/patent/US11298129B2

## CPC

- A61B 17/07207: {the staples being applied sequentially}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/0684: {having a forming anvil staying above the tissue during stapling}
- A61B 17/072: for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B 17/29: Forceps for use in minimally invasive surgery
- A61B 34/30: Surgical robots
- A61B 50/00: Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers (drapes specially adapted for instruments A61B46/10)
- A61B 50/20: Holders specially adapted for surgical or diagnostic appliances or instruments (drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02)
- A61B 90/03: {Automatic limiting or abutting means, e.g. for safety}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 90/08: {Accessories or related features not otherwise provided for}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 90/92: coded with colour
- A61B 90/94: coded with symbols, e.g. text
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect}
- A61B 2017/00389: {Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00473: {Distal part, e.g. tip or head (A61B2017/00464 takes precedence)}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00482: {with a code}
- A61B 2017/0053: {Loading magazines or sutures into applying tools}
- A61B 2017/00734: {battery operated}
- A61B 2017/00876: {magnetic}
- A61B 2017/00982: {General structural features}
- A61B 2017/07214: {Stapler heads}
- A61B 2017/07257: {characterised by its anvil}
- A61B 2017/07264: {characterised by its staple forming cavities, e.g. geometry or material}
- A61B 2017/07271: {characterised by its cartridge}
- A61B 2017/07278: {characterised by its sled or its staple holder}
- A61B 2017/07285: {characterised by its cutter}
- A61B 2017/2926: {Details of heads or jaws}
- A61B 2017/2936: {Pins in guiding slots}
- A61B 2017/2946: {Locking means}
- A61B 2050/007: {Locking clamps}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B 2090/038: {during shipment}
- A61B 2090/067: {for measuring angles}
- A61B 2090/0803: {Counting the number of times an instrument is used}
- A61B 2090/0807: {Indication means}
- A61B 2090/0808: {for indicating correct assembly of components, e.g. of the surgical apparatus}
- 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}
- A61B 2090/0814: {Preventing re-use}
- A61M 5/5086: {for indicating if defective, used, tampered with or unsterile}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method for operating a surgical stapling device that includes a lockout for preventing the surgical stapling device from operating is disclosed. The method includes installing a retainer on a staple cartridge to form a cartridge assembly. The method includes seating the cartridge assembly in the surgical stapling device to bring an authentication key on the retainer into actuation contact with the lockout to move the lockout out of a locked position to an unlocked position. The method further includes removing the retainer from the staple cartridge while retaining the lockout in the unlocked position.

## Claims

### Claim 1

A method for operating a surgical stapling device comprising a lockout for preventing the surgical stapling device from operating, wherein said method comprises:
installing a retainer on a staple cartridge to form a cartridge assembly, wherein the retainer is sized to cover a deck of the staple cartridge and comprises an authentication key protruding from a proximal end thereof;
initially inserting the cartridge assembly into the surgical stapling device to bring the authentication key on the retainer into initial actuation contact with the lockout in the surgical stapling device to move the lockout out of a locked position;
fully seating the cartridge assembly into the surgical stapling device to bring the authentication key on the retainer into further actuation contact with the lockout in the surgical stapling device to move the lockout into an unlocked position;
removing the retainer from the staple cartridge while retaining the lockout in the unlocked position; and
operating the surgical stapling device.

### Claim 2 (depends on 1)

The method of claim 1, wherein the surgical stapling device further comprises a first jaw and a second jaw movably supported relative to the first jaw for movement between an open position and a closed position, wherein the lockout retains the second jaw in the open position when the lockout is in the locked position, wherein when lockout is in the unlocked position, the second jaw is movable to the closed position, and wherein said operating comprises applying a closure motion to the second jaw to move the second jaw to the closed position.

### Claim 3 (depends on 1)

The method of claim 1, wherein the surgical stapling device comprises a firing member that is movable through a staple firing stroke from a starting position to an ending position within the staple cartridge, wherein the lockout retains the firing member in the starting position when the lockout is in the locked position, wherein when the lockout is in the unlocked position, the firing member is distally movable from the starting position, and wherein said operating comprises applying a firing motion to the firing member to move the firing member from the starting position to the ending position.

### Claim 4 (depends on 3)

The method of claim 3, wherein the surgical stapling device further comprises a second lockout configured to prevent the firing member from moving through the staple firing stroke when a spent staple cartridge is seated in the surgical stapling device, and wherein said method further comprises defeating the second lockout.

### Claim 5 (depends on 4)

The method of claim 4, wherein the second lockout comprises an abutment portion in the surgical stapling device that is configured to be contacted by the firing member when a spent staple cartridge is seated in the surgical stapling device, wherein the staple cartridge comprising the cartridge assembly seated in the surgical stapling device comprises a sled operably supported in an unfired position within the staple cartridge, and wherein said defeating comprises engaging the sled in the unfired position with the firing member to move the firing member into a position avoiding the abutment portion.

### Claim 6 (depends on 1)

The method of claim 1, wherein the lockout comprises a pair of lockout arms that are movable between the locked position and the unlocked position, wherein said initially inserting the cartridge assembly into the surgical stapling device further comprises bringing the authentication key on the retainer into initial actuation contact with the pair of lockout arms in the surgical stapling device to move the lockout arms out of the locked position, and wherein said fully seating the cartridge assembly into the surgical stapling device further comprises bringing the authentication key on the retainer into further actuation contact with the pair of lockout arms in the surgical stapling device to move the lockout arms into the unlocked position.

### Claim 7 (depends on 1)

The method of claim 1, wherein said removing the retainer from the staple cartridge further comprises disabling the retainer to prevent reuse of the retainer on another staple cartridge.

### Claim 8 (depends on 7)

The method of claim 7, wherein said disabling comprises moving the authentication key from a first insertion position wherein the authentication key is capable of the initial actuation contact when the cartridge assembly is initially seated in the surgical stapling device and the authentication key is capable of the further actuation contact when the cartridge assembly is fully seated in the surgical stapling device to a second disabled position wherein the authentication key is unable to be returned to the first insertion position.

### Claim 9 (depends on 7)

The method of claim 7, wherein the authentication key is coupled to a body portion of the retainer by a frangible connection, and wherein said disabling comprises breaking the frangible connection to detach the authentication key from the body portion.

### Claim 10 (depends on 7)

The method of claim 7, wherein said disabling comprises crushing the authentication key.

### Claim 11 (depends on 1)

The method of claim 1, further comprising limiting a number of times that the retainer is reusable on other staple cartridges to defeat another lockout in another surgical stapling device.

### Claim 12 (depends on 11)

The method of claim 11, wherein the retainer comprises a plurality of frangible attachment features configured to removably couple the retainer to a staple cartridge, and wherein said limiting comprises removing at least one of the frangible attachment features from the retainer after each use.

### Claim 13 (depends on 1)

The method of claim 1, wherein the lockout of the surgical stapling device is located on a first side of an axis defined by the cartridge assembly, and wherein said method further comprises:
reattaching the removed retainer after said removing to another staple cartridge to form another cartridge assembly configured for use with another surgical stapling device comprising another lockout for preventing the another surgical stapling device from operating, wherein the another lockout is located on a second side of the axis defined by the cartridge assembly;
initially inserting the another cartridge assembly into the another surgical stapling device to bring the authentication key on the retainer into initial actuation contact with the another lockout in the another surgical stapling device to move the another lockout out of another locked position; and
fully seating the another cartridge assembly into the another surgical stapling device to bring the authentication key on the retainer into further actuation contact with the another lockout in the another surgical stapling device to move the another lockout into another unlocked position.

### Claim 14 (depends on 13)

The method of claim 13, wherein said initially inserting the another cartridge assembly into the another surgical stapling device causes the authentication key on the retainer to laterally move the another lockout out of the another locked position.

### Claim 15 (depends on 1)

The method of claim 1, wherein said initially inserting the cartridge assembly into the surgical stapling device causes the authentication key on the retainer to vertically move the lockout out of the locked position.

### Claim 16

A method for operating a surgical stapling device comprising a pair of jaws, wherein one of the jaws is movable relative to the other jaw between an open position and a closed position, wherein the surgical stapling device further comprises of a lockout for preventing the surgical stapling device from operating, and wherein said method comprises:
inserting a deactivator tool into the surgical stapling device when the movable jaw is in the open position to move the lockout from a locked position to an unlocked position within the surgical stapling device;
retaining the lockout in the unlocked position;
removing the deactivator tool from the surgical stapling device;
seating a staple cartridge into one of the jaws of the surgical stapling device; and
operating the surgical stapling device.

### Claim 17 (depends on 16)

The method of claim 16, wherein said retaining comprises installing a deactivator insert into retaining engagement with the lockout while the lockout is in the unlocked position.

### Claim 18 (depends on 16)

The method of claim 16, wherein the deactivator tool is configured to be slidably supported on one of the jaws and movable between a first position and a deactivation position, and wherein said inserting comprises sliding said deactivator tool into said deactivation position wherein the deactivation tool moves the lockout from the locked position to the unlocked position.

### Claim 19 (depends on 16)

The method of claim 16, wherein said inserting comprises magnetically engaging the lockout with the deactivator tool to move the lockout from the locked position to the unlocked position.

### Claim 20 (depends on 16)

The method of claim 16, wherein said retaining comprises applying an adhesive member to the lockout when the lockout is in the unlocked position.