Surgical Stapling Apparatus with Predictive Algorithm

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Solution Overview

Problem

Existing surgical stapling procedures face challenges in maintaining a uniform tissue gap during clamping, leading to issues like contamination, infection, and tissue trauma due to high clamping forces and uneven staple closure, which can result in anastomosis failure and excessive bleeding.

Innovation Solution

A surgical device equipped with a motor and sensor system that adjusts firing parameters, such as clamp force and firing speed, based on real-time feedback to optimize staple formation and reduce tissue trauma, using a strain gauge to monitor clamp force and control the power applied to the tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If high clamping forces are applied to compress tissue to an adequately small tissue gap, then effective stapling is achieved, but the jaws may splay outwardly causing non-uniform tissue gap and staple formation failure

Engineering Contradiction:
Improvetissue gap uniformityVSAvoidclamping force
Core Design Contradiction:
Manufacturing precisionVSForce

Solution Approach 1:

A sensor detects the actual clamp force applied to the tissue, and this feedback signal is used by a controller to adjust the firing parameters of the stapler. The controller modifies the firing speed or wait time based on the detected clamp force to ensure uniform staple formation even when jaw splaying occurs under high clamping forces.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The firing parameters (speed or wait time) are dynamically changed based on the detected clamp force conditions. When high clamp force is detected causing jaw splay, the controller adjusts the firing parameters to compensate and maintain adequate staple formation despite the non-uniform tissue gap.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If constant closing rate is used during clamping, then the procedure is simple to control, but excessive power is exerted into the compressed tissue causing tissue trauma

Engineering Contradiction:
Improvecontrol simplicityVSAvoidtissue trauma
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The sensor provides feedback on the actual clamp force being applied to the tissue. The controller uses this feedback to dynamically adjust firing parameters, ensuring that staples are formed correctly even when varying closing rates are used to minimize tissue trauma while maintaining procedural simplicity.

Inventive Principle:
Principle #23Feedback

3Adaptability or versatility

If clamp force varies during stapling, then adaptation to different tissue conditions is achieved, but consistent staple formation becomes difficult

Engineering Contradiction:
Improvetissue condition adaptationVSAvoidstaple formation consistency
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The sensor detects variations in clamp force during stapling, and the controller adjusts firing parameters in response to these variations. This feedback mechanism maintains consistent staple formation despite changes in tissue compressibility or other tissue conditions that cause clamp force variations.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The firing parameters are made dynamic rather than fixed, allowing the controller to adjust speed or wait time in real-time based on detected clamp force conditions. This dynamic adjustment ensures consistent staple formation across varying tissue conditions.

Inventive Principle:
Principle #15Dynamics

4Strength

If jaw splay occurs under high clamping forces, then the structure can accommodate the force, but the tissue gap increases toward distal ends causing contamination risk

Engineering Contradiction:
Improvejaw structural strengthVSAvoidtissue contamination
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The sensor detects clamp force variations that indicate jaw splaying, and the controller adjusts firing parameters to compensate. By modifying firing speed or wait time based on detected conditions, the system ensures adequate tissue closure even when jaw splay causes increased tissue gap at distal ends, preventing contamination.

Inventive Principle:
Principle #23Feedback

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The device ensures consistent tissue closure within a target range, minimizing tissue trauma and preventing contamination by dynamically adjusting the power and speed of staple firing, thereby reducing the risk of infection and anastomosis failure.

Implementation Method 1

A sensor (e.g., a strain gauge) may be employed to detect a clamp force between the anvil assembly and the cartridge assembly

Methodology Applied
Scientific EffectStrain gauge measurement: Piezoresistive Effect

Data Source

PatentEP3403590A1Surgical stapling apparatus employing a predictive stapling algorithm
Publication Date: 2018.11.21 COVIDIEN LP
  • EP3403590A1 patent drawingFigure 1
  • EP3403590A1 patent drawingFigure 2
  • EP3403590A1 patent drawingFigure 3

AI summary

A surgical device is provided that includes a tool assembly having an anvil assembly and a cartridge assembly configured to grasp tissue therebetween, the cartridge assembly including a plurality of surgical fasteners. A motor is configured to fire one or more surgical fasteners. A sensor determines a first parameter of the tool assembly and a control system adjusts a second parameter of the motor used to fire the one or more surgical fasteners based on the first parameter detected by the sensor.