Circular Stapling Instrument Anvil Gap Adjustment Mechanism

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Solution Overview

Problem

Current surgical stapling instruments face challenges in ensuring a secure and leak-proof end-to-end anastomosis between sections of the digestive tract, particularly in adjusting the gap distance between the anvil and stapling head to prevent leakage or tissue damage during the anastomosis process.

Innovation Solution

A circular stapling instrument with a handle assembly that includes a rotatable knob and trigger mechanism, allowing for precise adjustment of the gap distance between the anvil and stapling head through a trocar actuation rod with coarse and fine threading, ensuring proper tissue compression and staple formation, and featuring a lockout mechanism to prevent improper actuation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the gap distance between the anvil and stapling head is not precisely adjusted, then the anastomosis may be insecure or leak-prone, but precise adjustment requires complex mechanisms increasing device complexity

Engineering Contradiction:
Improveanastomosis securityVSAvoidadjustment mechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The instrument employs a dynamic adjustment mechanism where the gap distance between the anvil and stapling head can be varied during operation. The rotor's rotation relative to the stator drives the trocar actuation rod, enabling real-time modification of the gap distance to achieve secure anastomosis while maintaining operational flexibility

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent replaces complex manual adjustment mechanisms with a motorized drive system. The motor coupled to the rotor provides automated control of the gap distance, substituting intricate mechanical linkages with a more compact and controllable electromechanical system that reduces overall device complexity

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Speed

If coarse threading is used on the trocar actuation rod for rapid adjustment, then adjustment speed increases but positioning precision decreases

Engineering Contradiction:
Improveadjustment speedVSAvoidgap distance precision
Core Design Contradiction:
SpeedVSManufacturing precision

Solution Approach 1:

The adjustment mechanism is segmented into two distinct threading sections on the trocar actuation rod: a first section with coarse threading for rapid initial positioning, and a second section with fine threading for precise final adjustment. This segmentation allows the operator to efficiently move from rough positioning to precise gap distance control

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The dual-threading system enables dynamic transition between adjustment phases. The rotor can engage different sections of the trocar actuation rod depending on the adjustment stage, allowing the system to adapt its resolution and speed characteristics to match the operational requirements at each phase

Inventive Principle:
Principle #15Dynamics

3Manufacturing precision

If the anvil is held firmly against the tissue during stapling, then staple formation is improved but tissue damage or leakage risk increases

Engineering Contradiction:
Improvestaple formation qualityVSAvoidtissue damage
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The instrument provides dynamic control of the anvil-tissue interface through variable gap distance adjustment. By precisely controlling the distance between the anvil and stapling head, the system optimizes tissue compression during stapling to achieve proper staple formation while preventing excessive force that could cause tissue damage or leakage

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The lockout mechanism provides feedback control by preventing actuation unless the gap distance is within the optimal range. This ensures that the anvil is positioned correctly relative to the tissue before stapling begins, promoting secure staple formation without excessive compression that could harm the tissue

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS10478189B2Method of applying an annular array of staples to tissue
Publication Date: 2019.11.19 CILAG GMBH INTERNATIONAL
  • US10478189B2 patent drawing
  • US10478189B2 patent drawing
  • US10478189B2 patent drawing

AI summary

A surgical instrument includes a body, a shaft assembly, a stapling head assembly, an anvil, an anvil adjustment assembly, a trigger, and a lockout assembly. The stapling head assembly is operable to drive an annular array of staples. The anvil is configured to couple with the stapling head assembly. The anvil adjustment assembly includes a translating member, which translates relative to the body to thereby adjust the longitudinal position of the anvil relative to the stapling head assembly. The trigger is operable to actuate the stapling head assembly. The lockout assembly includes an electrically powered braking feature. A method of operating the surgical instrument includes providing the lockout assembly in a first state to permit translation of the translating member. The translating member is then translated. The lockout assembly is then transitioned to a second state to prevent further translation of the translating member.