MIM Surgical Stapler Anvil for Precise Staple Pocket Alignment

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Solution Overview

Problem

Existing circular surgical staplers lack a cost-effective and reliable method for manufacturing anvils that ensure precise alignment and deformation of staples, leading to inconsistent staple formation and potential leaks at anastomosis sites.

Innovation Solution

The development of anvils manufactured using metal injection molding (MIM) with subsequent coining or electrochemical machining of staple forming pockets, allowing for precise deformation of staples and improved surface properties, combined with a shank and head assembly that ensures consistent angular alignment with the stapling head.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If traditional manufacturing methods are used for anvils, then manufacturing cost is reduced, but manufacturing precision and consistency of staple formation deteriorate

Engineering Contradiction:
Improvestaple formation precisionVSAvoidmanufacturing cost
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent applies metal injection molding (MIM) technology to manufacture the anvil, which involves changing the manufacturing parameters and process methodology. MIM allows for precise control of material properties and geometric features during the molding process, enabling consistent staple formation pockets with high precision while maintaining cost-effectiveness through automated manufacturing and material efficiency.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If simple manufacturing processes are used for anvils, then manufacturing complexity is reduced, but reliability of staple deformation deteriorates

Engineering Contradiction:
Improvestaple deformation reliabilityVSAvoidmanufacturing process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs metal injection molding with controlled material parameters and processing conditions to ensure reliable staple deformation. The MIM process allows for precise control of density, surface finish, and geometric accuracy of the staple forming pockets, which directly impacts the reliability of staple deformation while the automated nature of MIM keeps the overall manufacturing process manageable.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If conventional anvil manufacturing is used, then manufacturing time is reduced, but consistency of staple formation deteriorates

Engineering Contradiction:
Improvestaple formation consistencyVSAvoidmanufacturing cycle time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The metal injection molding process incorporates preliminary action by pre-forming the anvil with precisely controlled staple formation pockets during the molding stage itself. This eliminates the need for subsequent extensive machining or finishing operations, as the critical geometric features are established with high consistency during the initial molding process, reducing both time and improving consistency.

Inventive Principle:
Principle #10Preliminary action

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

This approach results in consistently formed staples with improved surface properties, reducing the risk of leaks and ensuring precise alignment, thereby enhancing the reliability and effectiveness of anastomosis procedures.

Implementation Method 1

forming the head of a surgical circular stapler using a metal injection molding process

Methodology Applied
Scientific EffectMetal injection molding:

Implementation Method 2

a portion of at least one staple forming pocket of the annular array of staple forming pockets is coined or electrochemical machined

Methodology Applied
Scientific EffectCoining: Plasticity

Implementation Method 3

a portion of at least one staple forming pocket of the annular array of staple forming pockets is coined or electrochemical machined

Methodology Applied
Scientific EffectElectrochemical machining: Electrolysis

Data Source

PatentUS12023032B2Anvil for circular surgical stapler and associated method of manufacture with MIM
Publication Date: 2024.07.02 CILAG GMBH INTERNATIONAL
  • US12023032B2 patent drawing
  • US12023032B2 patent drawing
  • US12023032B2 patent drawing

AI summary

A method is used to manufacture an anvil of a surgical circular stapler. The anvil includes a head and a shank extending proximally from the head. The method includes forming the head of a surgical circular stapler using a metal injection molding process. The method also includes forming an annular array of staple forming pockets in the head. The method also includes machining the shank of the surgical circular stapler. The method also includes coupling together the head and the shank of the surgical circular stapler that were separately manufactured.