Variable Gap Staple Cartridge for Hemostasis and Anastomotic Strength

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Solution Overview

Problem

Existing surgical stapling instruments face challenges in achieving a balance between anastomotic strength and hemostasis, particularly due to the use of constant gaps between the anvil and staple cartridge, which can lead to inadequate tissue compression and bleeding.

Innovation Solution

The surgical stapling instrument features a staple cartridge with a variable pressure gradient, where the tissue contacting surfaces are stepped, allowing for higher compressive forces at the center and lower forces at the edges, enabling the use of smaller staples and improving hemostasis through a gradual compression gradient.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a constant gap between anvil and staple cartridge is used, then the device structure is simple, but tissue compression is inadequate leading to poor hemostasis

Engineering Contradiction:
ImprovehemostasisVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The anvil and staple cartridge are designed with non-uniform gaps: a first gap at the centerline and a second gap at the lateral edges, where the first gap differs from the second gap. This local variation in gap size creates different compression forces at different locations, improving hemostasis where needed without requiring complete structural redesign

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The gap dimension between anvil and staple cartridge is changed from a constant value to a variable value that differs at different locations. Specifically, the distance between the tissue contacting surface of the anvil and the tissue contacting surface of the staple cartridge varies, creating a pressure gradient that enhances tissue compression and hemostatic effect

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If higher compressive forces are applied to improve hemostasis, then bleeding is reduced, but tissue trauma increases

Engineering Contradiction:
ImprovebleedingVSAvoidtissue trauma
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

Different compressive forces are applied at different locations: higher compression at the centerline where it is most needed for hemostasis, and lower compression at the lateral edges to minimize tissue trauma. This localized differentiation allows effective bleeding control without excessive trauma

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

Full uniform compression across the entire tissue area is avoided. Instead, compression is applied partially and selectively - excessive compression is used only at the centerline for hemostasis, while lateral regions receive moderate compression, preventing unnecessary tissue damage

Inventive Principle:
Principle #16Partial or excessive action

3Strength

If larger staples are used to ensure anastomotic strength, then joint strength is improved, but the ability to compress tissue effectively is reduced

Engineering Contradiction:
Improveanastomotic strengthVSAvoidtissue compression force
Core Design Contradiction:
StrengthVSForce

Solution Approach 1:

The patent employs different staple sizes at different locations: smaller staples at the centerline where tissue compression is most effective, and larger staples at the lateral edges where greater anastomotic strength is needed. This local differentiation allows each staple size to be optimized for its specific function

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

Rather than using uniformly large staples throughout, the patent uses large staples only partially - specifically at the lateral edges where structural strength is most critical. The center region uses smaller staples that are sufficient for its needs and provide better compression characteristics

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentEP1857057B1Surgical stapling instruments including a cartridge having multiple staple sizes
Publication Date: 2016.12.14 COVIDIEN LP
  • EP1857057B1 patent drawingFigure 1
  • EP1857057B1 patent drawingFigure 2~2A
  • EP1857057B1 patent drawingFigure 3A~3B

AI summary

A surgical stapling apparatus includes a staple cartridge and an anvil member. The staple cartridge includes a plurality of surgical fasteners disposed in rows of retention slots. The staple cartridge may have an annular or linear configuration of retention slots. The tissue contacting surface of the staple cartridge may be tapered or stepped. The anvil member has a tissue contacting surface that includes a number of pockets arranged for substantially aligning with the retention slots. In addition, the tissue contacting surface of the anvil member may complement the tissue contacting surface of the staple cartridge.