# US 12,178,536 B2 · Disabling surgical tools due to manual bailout

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- Number: US 12,178,536 B2
- Document ID: US12178536B2
- Status: Granted
- Kind: B2
- Application number: 18/506,000
- Filed: 2023-11-09
- Published: 2024-02-29
- Granted: 2024-12-31
- Earliest claimed: 2019-05-31
- Assignees: Cilag GmbH International
- Applicants: Cilag GmbH International
- Inventors: Mark D. Overmyer; Benjamin Lawrence Bertram; Christopher A. Denzinger; Robert Louis Koch, Jr.
- Web page: https://patentgrep.com/patent/US12178536B2

## CPC

- A61B 34/37: Leader-follower robots (A61B34/35 takes precedence)
- 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 17/072: for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B 17/07207: {the staples being applied sequentially}
- A61B 34/74: {Manipulators with manual electric input means}
- A61B 90/03: {Automatic limiting or abutting means, e.g. for safety}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 34/71: {Manipulators operated by drive cable mechanisms}
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2017/00407: {Ratchet means}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/07214: {Stapler heads}
- A61B 2017/07285: {characterised by its cutter}
- A61B 2017/2927: {the angular position of the head being adjustable with respect to the shaft}
- A61B 2017/2943: {Toothed members, e.g. rack and pinion}
- A61B 2034/305: {Details of wrist mechanisms at distal ends of robotic arms}
- A61B 2034/742: {Joysticks}
- A61B 2090/066: {for measuring torque}
- A61B 2090/0814: {Preventing re-use}
- A61B 2090/371: {with simultaneous use of two cameras}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A surgical tool includes a drive housing removably coupled to a tool driver of a robotic surgical system, a shaft extending from the drive housing, an end effector arranged at an end of the shaft, and a computer system. The computer system is programmed to send a command signal to a motor of the tool driver to drive rotation of a drive shaft mounted within the drive housing, monitor torque and rotational motion of the motor with a torque sensor and a rotary encoder, respectively, in communication with the computer system, measure an unexpected change in the torque or the rotational motion of the motor with the torque sensor or the rotary encoder when the surgical tool is manually bailed out by manually rotating the drive shaft and backdriving the motor, report the unexpected change as a bailout signal, and disable the surgical tool once the bailout signal is received.

## Claims

### Claim 1

A surgical tool, comprising:
a drive housing configured to be removably coupled to a tool driver of a robotic surgical system;
a shaft extending from the drive housing;
an end effector arranged at an end of the shaft; and
a computer system including a memory and a processor operable to execute commands stored on the memory, the computer system being programmed to:
send a command signal to a motor of the tool driver to drive rotation of a drive shaft mounted within the drive housing;
monitor torque and rotational motion of the motor with a torque sensor and a rotary encoder, respectively, in communication with the computer system;
measure an unexpected change in at least one of the torque and the rotational motion of the motor with at least one of the torque sensor and the rotary encoder when the surgical tool is manually bailed out by manually rotating the drive shaft and backdriving the motor;
report the unexpected change as a bailout signal; and
disable the surgical tool once the bailout signal is received.

### Claim 2 (depends on 1)

The surgical tool of claim 1, wherein, by disabling the surgical tool, the computer system is further programmed to render the surgical tool unavailable for future procedures.

### Claim 3 (depends on 2)

The surgical tool of claim 2, wherein rendering the surgical tool unavailable for future procedures comprises at least one of:
allowing a knife located at the end effector to be retracted to a home position;
preventing the knife from extending;
permitting actuation of opposing jaws of the end effector;
permitting articulation of a wrist interposing the end effector and the shaft; and
permitting rotation of the shaft.

### Claim 4 (depends on 1)

The surgical tool of claim 1, wherein, by disabling the surgical tool, the computer system is further programmed to:
generate an alert perceivable by a user that the surgical tool has been bailed out; and
override the alert and thereby allowing the user to proceed with operation of the surgical tool.

### Claim 5 (depends on 1)

The surgical tool of claim 1, wherein the robotic surgical system is a first robotic surgical system and the surgical tool further includes an internal computer housed within the drive housing and including an internal computer memory, and wherein the computer system is further programmed to:
communicate the bailout signal to the internal computer such that the bailout signal is stored in the internal computer memory;
upon installing the surgical tool on a tool driver of a second robotic surgical system, query the internal computer memory with the second robotic surgical system and determine that the surgical tool was previously bailed out; and
initiate one or more remedial actions to ensure safe operation of the surgical tool on the second robotic surgical system.

### Claim 6 (depends on 5)

The surgical tool of claim 5, wherein initiating the one or more remedial actions comprises disabling the surgical tool and thereby rendering the surgical tool unavailable for future procedures.

### Claim 7 (depends on 5)

The surgical tool of claim 5, wherein initiating the one or more remedial actions comprises generating an alert that informs a user that the surgical tool was previously bailed out.

### Claim 8 (depends on 7)

The surgical tool of claim 7, wherein generating the alert comprises displaying detailed instructions for the user on a visual display.

### Claim 9 (depends on 1)

The surgical tool of claim 1, wherein the surgical tool is manually bailed out using a bailout mechanism that includes:
a key mounted within the drive housing; and
a transfer drive shaft interconnected by gearing to the drive shaft and a firing member, the firing member being longitudinally movable within the drive housing and operatively coupled to a knife located at the end effector,
wherein a user accesses the key and manually couples the key to the transfer drive shaft, and wherein manually rotating the key in a first angular direction drives the firing member and the knife in a first longitudinal direction.

### Claim 10 (depends on 9)

The surgical tool of claim 9, wherein the key is operatively coupled to the transfer drive shaft at a bailout cap having one or more ramped surface features, and wherein manually rotating the key in a second angular direction opposite the first angular direction ratchets the key over the one or more ramped surface features as the key is rotated in the second angular direction.

### Claim 11 (depends on 1)

The surgical tool of claim 1, wherein the surgical tool is manually bailed out using a bailout mechanism that includes:
a bailout tool arranged on an exterior of the drive housing and operatively coupled to a primary gear mounted within the drive housing, the primary gear being interconnected by gearing to the drive shaft and rotatably mounted to a closure yoke, wherein the closure yoke is coupled to a closure tube of the shaft and movable to actuate opposing jaws of the end effector, and
wherein manually rotating the bailout tool drives the closure yoke and the closure tube in a longitudinal direction to actuate the opposing jaws.

### Claim 12 (depends on 1)

The surgical tool of claim 1, wherein the computer system is further programmed to communicate the bailout signal to a central database to disable the surgical tool.

### Claim 13

A surgical tool, comprising:
a drive housing configured to be removably coupled to a tool driver of a robotic surgical system;
a shaft extending from the drive housing;
an end effector arranged at an end of the shaft; and
a computer system including a memory and a processor operable to execute commands stored on the memory, the computer system being programmed to:
send a command signal to a motor of the tool driver to drive rotation of a drive shaft mounted within the drive housing and thereby commence a firing sequence of the end effector;
set a bailout Boolean value to “true” in the computer system once the command signal is sent to commence the firing sequence;
set the bailout Boolean value to “false” in the computer system if the firing sequence is fully completed; and
maintain the bailout Boolean value as “true” if the surgical tool is manually bailed out before completing the firing sequence.

### Claim 14 (depends on 13)

The surgical tool of claim 13, wherein the firing sequence of the end effector comprises:
distally advancing a knife of the end effector relative to opposing jaws of the end effector; and
retracting the knife to a home position.

### Claim 15 (depends on 13)

The surgical tool of claim 13, wherein the computer system is further programmed to disable the surgical tool when the bailout Boolean value is “true” following the surgical tool being manually bailed out.

### Claim 16 (depends on 15)

The surgical tool of claim 15, wherein, by disabling the surgical tool, the computer system is further programmed to at least one of render the surgical tool unavailable for future procedures or generate an alert that informs a user that the surgical tool was previously bailed out.

### Claim 17 (depends on 13)

The surgical tool of claim 13, wherein the robotic surgical system is a first robotic surgical system and the surgical tool further includes an internal computer housed within the drive housing and including an internal computer memory, and wherein the computer system is further programmed to:
communicate the bailout Boolean value as “true” to the internal computer and store the bailout Boolean value in the internal computer memory;
upon manually bailing out the surgical tool before completing the firing sequence and subsequently installing the surgical tool on a tool driver of a second robotic surgical system, query the internal computer memory with the second robotic surgical system and determine that the surgical tool was previously bailed out; and
initiate one or more remedial actions to ensure safe operation of the surgical tool on the second robotic surgical system.

### Claim 18 (depends on 17)

The surgical tool of claim 17, wherein the one or more remedial actions include disabling the surgical tool and thereby rendering the surgical tool unavailable for future procedures.

### Claim 19 (depends on 17)

The surgical tool of claim 17, wherein the one or more remedial actions include generating an alert that informs a user that the surgical tool was previously bailed out.

### Claim 20 (depends on 19)

The surgical tool of claim 19, wherein the alert includes detailed instructions displayed for the user on a visual display.