# US 11,298,130 B2 · Staple cartridge retainer with frangible authentication key

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- Number: US 11,298,130 B2
- Document ID: US11298130B2
- Status: Granted
- Kind: B2
- Application number: 16/453,330
- Filed: 2019-06-26
- Published: 2020-08-20
- Granted: 2022-04-12
- Earliest claimed: 2019-02-19
- Assignees: Cilag GmbH International
- Applicants: Cilag GmbH International
- Inventors: Gregory J. Bakos; Chad P. Boudreaux; Chad E. Eckert; Morgan R. Hunter
- Web page: https://patentgrep.com/patent/US11298130B2

## 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 retainer for use with a staple cartridge that is configured for use with a stapling device is disclosed. The retainer comprises a retainer body that is configured to be removably coupled to the staple cartridge to form a cartridge assembly. The retainer further comprises an authentication key that is oriented in a first configuration to defeat a lockout in the surgical stapling device when the cartridge assembly is seated in the surgical stapling device. The authentication key is movable to a second configuration after the cartridge assembly is removed from the stapling device such that the authentication key is unable to return to the first configuration.

## Claims

### Claim 1

A retainer for use with a staple cartridge configured for use with a surgical stapling device comprising a lockout for preventing operation of the surgical stapling device, wherein the staple cartridge comprises a cartridge body configured to be operably supported in the surgical stapling device, wherein the cartridge body defines a cartridge deck surface and stores a plurality of surgical staples therein that are configured to be ejected from the cartridge body through openings in the cartridge deck surface, and wherein said retainer comprises a retainer body configured to be removably mounted to the staple cartridge to cover at least a portion of the cartridge deck surface to form a cartridge assembly, wherein said retainer body comprises an authentication key oriented in a first configuration in which said authentication key is positioned to defeat the lockout when said cartridge assembly is seated in the surgical stapling device, and wherein said authentication key is movable to a second configuration in which said authentication key is unable to return to said first configuration when said retainer body is supported on another cartridge deck surface of another staple cartridge.

### Claim 2 (depends on 1)

The retainer of claim 1, wherein said authentication key is attached to said retainer body by a frangible feature configured to be broken when the retainer body is removed from the cartridge deck surface.

### Claim 3 (depends on 2)

The retainer of claim 2, further comprising a tether attaching said authentication key to said retainer body.

### Claim 4 (depends on 2)

The retainer of claim 2, wherein said frangible feature comprises a frangible hinge.

### Claim 5 (depends on 1)

The retainer of claim 1, wherein said retainer body is fabricated from a first material that degrades at a first rate, and wherein at least a portion of said authentication key is fabricated from a second material that degrades at a second rate that is greater than the first rate.

### Claim 6 (depends on 1)

The retainer of claim 1, wherein said retainer body comprises at least one weakened area configured to permit said retainer body to be deformed into a deformed state during removal from the staple cartridge, and wherein said deformed state prevents said retainer from being reinstalled onto the another staple cartridge.

### Claim 7 (depends on 6)

The retainer of claim 6, wherein said at least one weakened area comprises at least one slit in one side of said retainer body, and wherein said slit does not completely extend through a cross-sectional thickness of said retainer body.

### Claim 8 (depends on 1)

The retainer of claim 1, wherein the lockout comprises a lockout arm that is movable between a jaw lockout position wherein a movable jaw of the surgical stapling device is prevented from moving from an open position to a closed position and a jaw closure position wherein the movable jaw is movable from the open position to the closed position, and wherein said authentication key is configured to move the lockout arm from the jaw lockout position to the jaw closure position when said cartridge assembly is seated in the surgical stapling device.

### Claim 9 (depends on 8)

The retainer of claim 8, wherein the lockout arm is lateral movable between the jaw lockout position and the jaw closure position, and wherein said authentication key is configured to laterally move the lockout arm from the jaw lockout position to the jaw closure position when said cartridge assembly is seated in the surgical stapling device.

### Claim 10 (depends on 1)

The retainer of claim 1, wherein the surgical stapling device further comprises a firing member, wherein the firing member is movable between a starting position and an ending position during a staple firing stroke, and wherein the lockout comprises a lockout member movable between a locked position wherein the lockout member prevents the firing member from distally moving from the starting position and an unlocked position wherein the firing member is movable from the starting position to the ending position, and wherein said authentication key is configured to move the lockout member from the locked position to the unlocked position when said cartridge assembly is seated in the surgical stapling device.

### Claim 11 (depends on 10)

The retainer of claim 10, wherein the lockout member is laterally movable between the locked position and the unlocked position, and wherein said authentication key is configured to laterally move the lockout member from the locked position to the unlocked position when said cartridge assembly is seated in the surgical stapling device.

### Claim 12

A retainer for use with a staple cartridge, wherein the staple cartridge comprises a cartridge body in which a plurality of surgical staples are stored therein and are configured to be ejected therefrom through corresponding openings in a deck of the staple cartridge, wherein the staple cartridge is configured for use with a surgical stapling device comprising a lockout for preventing operation of the surgical stapling device, wherein said retainer comprises:
a retainer body sized to cover the openings in the deck of the staple cartridge when said retainer is removably coupled to the staple cartridge to form a cartridge assembly; and
an authentication key protruding from said retainer body, wherein said authentication key is oriented in a first configuration in which said authentication key is positioned to defeat the lockout when said cartridge assembly is seated in the surgical stapling device, and wherein said authentication key is movable to a second configuration in which said authentication key is unable to return to said first configuration when said retainer body is supported on another staple cartridge.

### Claim 13 (depends on 12)

The retainer of claim 12, wherein said authentication key protrudes proximally beyond a proximal end of said retainer body.

### Claim 14 (depends on 13)

The retainer of claim 13, wherein said authentication key is attached to said retainer body by a frangible feature configured to be broken when said retainer body is removed from the staple cartridge.

### Claim 15 (depends on 14)

The retainer of claim 14, further comprising a tether attaching said authentication key to said retainer body.

### Claim 16 (depends on 14)

The retainer of claim 14, wherein said frangible feature comprises a frangible hinge.

### Claim 17 (depends on 12)

The retainer of claim 12, wherein said retainer body is fabricated from a first material that degrades at a first rate, and wherein at least a portion of said authentication key is fabricated from a second material that degrades at a second rate that is greater than the first rate.

### Claim 18 (depends on 12)

The retainer of claim 12, wherein said retainer body comprises at least one weakened area configured to permit said retainer body to be deformed into a deformed state during removal from the staple cartridge, and wherein said deformed state prevents said retainer from being reinstalled onto the another staple cartridge.

### Claim 19 (depends on 18)

The retainer of claim 18, wherein said at least one weakened area comprises at least one slit in one side of said retainer body, and wherein said slit does not completely extend through a cross-sectional thickness of said retainer body.

### Claim 20

A retainer for use with a staple cartridge configured for use with a surgical stapling device comprising a lockout for preventing operation of the surgical stapling device, wherein said retainer comprises a retainer body configured to be mounted to the staple cartridge to form a cartridge assembly, wherein said retainer body comprises an authentication key oriented in a first configuration wherein said authentication key is positioned to defeat the lockout when said cartridge assembly is seated in the surgical stapling device, wherein said authentication key is movable to a second configuration wherein said authentication key is unable to return to said first configuration when said retainer body is supported on another staple cartridge, wherein said retainer body is fabricated from a first material that degrades at a first rate, and wherein at least a portion of said authentication key is fabricated from a second material that degrades at a second rate that is greater than the first rate.

### Claim 21 (depends on 20)

The retainer of claim 20, wherein the lockout comprises a lockout arm that is movable between a jaw lockout position wherein a movable jaw of the surgical stapling device is prevented from moving from an open position to a closed position and a jaw closure position wherein the movable jaw is movable from the open position to the closed position, and wherein said authentication key is configured to move the lockout arm from the jaw lockout position to the jaw closure position when said cartridge assembly is seated in the surgical stapling device.

### Claim 22 (depends on 20)

The retainer of claim 20, wherein the surgical stapling device further comprises a firing member, wherein the firing member is movable between a starting position and an ending position during a staple firing stroke, wherein the lockout comprises a lockout member movable between a locked position wherein the lockout member prevents the firing member from distally moving from the starting position and an unlocked position wherein the firing member is movable from the starting position to the ending position, and wherein said authentication key is configured to move the lockout member from the locked position to the unlocked position when said cartridge assembly is seated in the surgical stapling device.

### Claim 23 (depends on 21)

The retainer of claim 21, wherein the lockout arm is laterally movable between the jaw lockout position and the jaw closure position, and wherein said authentication key is configured to laterally move the lockout arm from the jaw lockout position to the jaw closure position when said cartridge assembly is seated in the surgical stapling device.

### Claim 24 (depends on 22)

The retainer of claim 22, wherein the lockout member is laterally movable between the locked position and the unlocked position, and wherein said authentication key is configured to laterally move the lockout member from the locked position to the unlocked position when said cartridge assembly is seated in the surgical stapling device.