Surgical Staple Line Reinforcement Clip Design

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Solution Overview

Problem

Current surgical stapling instruments lack an effective mechanism to reinforce the staple line post-surgery, leading to potential bleeding and tissue separation issues.

Innovation Solution

A reinforcement clip comprising a crown, legs, and teeth, made of a deformable material, is used to anchor the staple line, which can be collapsed around staples by a surgical applier and retained in place, ensuring secure closure and hemostasis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical stapling instruments are used to seal severed tissue layers, then tissue sealing is achieved, but the staple line lacks reinforcement leading to potential bleeding and tissue separation

Engineering Contradiction:
Improvestaple line securityVSAvoidinstrument structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The reinforcement clip is nested within the staple cartridge, allowing it to be delivered through the same instrument channel. The clip is positioned to overlay the staple line after deployment, with its legs receiving the staples to secure them together, providing reinforcement without requiring a separate instrument.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The reinforcement clip acts as an intermediary element between the staples and the tissue layers. It receives and secures the staples through its legs, while its body overlays the staple line to provide additional reinforcement, preventing bleeding and tissue separation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a reinforcement clip is added to overlay and secure the staple line, then staple line reinforcement is achieved, but the device complexity increases

Engineering Contradiction:
Improvestaple line reinforcementVSAvoidclip structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The reinforcement clip is divided into distinct functional segments: a body portion that overlays the staple line, legs that receive and secure the staples, and teeth that engage the tissue layers. This segmentation allows each component to perform its specific function efficiently while maintaining overall structural simplicity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reinforcement clip is constructed from a deformable material that allows it to be compressed by the applier jaws during delivery and then expand to its configured shape at the surgical site. This flexibility enables the clip to conform to the tissue and staple line while maintaining structural integrity for reinforcement.

Inventive Principle:
Principle #30Flexible shells and thin films

3Ease of operation

If the reinforcement clip is made of deformable material to allow collapsing by applier jaws, then ease of delivery is improved, but the clip's structural strength may be compromised

Engineering Contradiction:
Improveclip deliveryVSAvoidclip structural integrity
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The reinforcement clip transitions from a compressed, low-volume state during delivery to an expanded, structurally intact state at the surgical site. The deformable material allows the clip to be collapsed by the applier jaws for easy delivery through the instrument channel, then expands to its configured shape to provide reinforcement while maintaining structural integrity.

Inventive Principle:
Principle #15Dynamics

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 reinforcement clip effectively secures the staple line, reducing bleeding and tissue separation, allowing for easy removal of the applier while maintaining clamping pressure, thereby enhancing surgical outcomes.

Implementation Method 1

the crown comprises a deformable material. The reinforcement clip is malleable such that the jaws of the applier may be closed around the reinforcement clip causing the reinforcement clip to collapse around staples

Methodology Applied
Scientific EffectDeformation: Deformation

Data Source

PatentEP3461428B1Surgical instrument with staple reinforcement clip
Publication Date: 2022.11.09 ETHICON ENDO SURGERY INC
  • EP3461428B1 patent drawingFigure 1A~1B
  • EP3461428B1 patent drawingFigure 2
  • EP3461428B1 patent drawingFigure 3A

AI summary

An apparatus comprises a surgical instrument having a cutter and a stapler. The cutter is operable to sever a portion of tissue. The apparatus further comprises a plurality of staples where the stapler is operable to introduce the plurality of staples into tissue to form a staple line. The apparatus further comprises a reinforcement clip. The reinforcement clip is operable to be in selective communication with the staple line. The reinforcement clip comprises a crown, a leg portion, and a teeth portion. In some versions, the leg portion has a width operable to cover the area defined by the staple line. In some versions, the teeth portion is configured to anchor into tissue.