Surgical Stapler Knife MIM-HIP Manufacturing for Tight Tolerances

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Solution Overview

Problem

Conventional manufacturing processes for surgical stapler knives are time-consuming, expensive, and inefficient, with conventional machining techniques generating waste and requiring tight tolerances in some areas but not others, which can affect the performance and efficiency of the instrument.

Innovation Solution

The use of a manufacturing process combining metal injection molding (MIM) and hot isostatic pressing (HIP) to create surgical stapler knives, where specific features are machined to achieve tighter tolerances and improve performance, such as cutting edges and sliding interfaces, while maintaining a cost-effective and efficient production method.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional machining techniques are used to manufacture surgical stapler knives, then tight tolerances can be achieved in specific areas, but the manufacturing process is time-consuming and expensive

Engineering Contradiction:
Improvedimensional tolerancesVSAvoidmanufacturing time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The knife body is pre-formed using metal injection molding to achieve near-net shape with good dimensional tolerances, eliminating the need for extensive subsequent machining operations. This preliminary formation action reduces both manufacturing time and cost while maintaining precision requirements.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The manufacturing process transitions from conventional machining to metal injection molding, changing the fundamental manufacturing parameter from subtractive material removal to formative shaping. This parameter change enables simultaneous achievement of tight tolerances and reduced manufacturing time through process optimization.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If conventional machining techniques are used to manufacture surgical stapler knives, then dimensional tolerances can be controlled, but material waste is generated and production efficiency is reduced

Engineering Contradiction:
Improvedimensional tolerancesVSAvoidmaterial waste
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The knife is pre-formed using metal injection molding to achieve near-net shape, minimizing the amount of material that needs to be removed in subsequent operations. This preliminary forming action dramatically reduces material waste while maintaining dimensional tolerances.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The metal injection molding process enables local control of material properties and dimensional precision in critical areas of the knife, such as cutting edges and sliding interfaces, while using less material overall compared to conventional machining from solid stock.

Inventive Principle:
Principle #3Local quality

3Manufacturing precision

If conventional machining techniques are used to manufacture surgical stapler knives, then tight tolerances can be achieved in some areas, but the manufacturing cost increases

Engineering Contradiction:
Improvedimensional tolerancesVSAvoidmanufacturing cost
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The knife body is pre-formed using metal injection molding to achieve near-net shape with good dimensional tolerances, eliminating the need for extensive and expensive subsequent machining operations. This preliminary formation action significantly reduces manufacturing cost while maintaining precision requirements.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The manufacturing process transitions from conventional machining to metal injection molding, changing the fundamental manufacturing parameter from subtractive material removal to formative shaping. This parameter change enables cost-effective production with maintained dimensional tolerances through process optimization and reduced operational complexity.

Inventive Principle:
Principle #35Parameter changes

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 knives with improved dimensional tolerances, reduced wear, and enhanced cutting performance, leading to more efficient and cost-effective surgical stapling and severing operations with reduced material waste.

Implementation Method 1

forming the knife using metal injection molding

Methodology Applied
Scientific EffectMetal injection molding:

Implementation Method 2

hot isostatic pressing the molded knife

Methodology Applied
Scientific EffectHot isostatic pressing: Hot Isostatic Pressing

Data Source

PatentUS12059151B2Knife for surgical stapler and associated method of manufacture with MIM and HIP
Publication Date: 2024.08.13 CILAG GMBH INTERNATIONAL
  • US12059151B2 patent drawing
  • US12059151B2 patent drawing
  • US12059151B2 patent drawing

AI summary

A method is used to manufacture a knife of an end effector of a surgical instrument. The method includes forming the knife using metal injection molding. The knife has at least one feature having a molded shape. The method also includes machining the at least one feature of the knife to have a machined shape without machining the entire knife. The method also includes incorporating the knife into the end effector of the surgical instrument.