Collapsible Staple Driver for Variable Tissue Thickness

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Solution Overview

Problem

Existing surgical stapling instruments face challenges in accommodating varying tissue thicknesses, leading to issues such as loose staples in thin tissues and excessive compressive force in thick tissues, which can result in necrosis, bleeding, or poor staple formation.

Innovation Solution

A surgical stapling system with a deformable member and a driver that adjusts staple formation based on tissue thickness, using a cam mechanism to move the staple toward an anvil, and a staple cartridge with multiple drivers to accommodate different staple quantities and tissue thicknesses, ensuring proper staple formation across a range of tissue thicknesses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a fixed-height driver is used to deploy staples, then the staple formation is consistent for standard tissue thickness, but loose staples occur in thin tissues and excessive compressive force occurs in thick tissues

Engineering Contradiction:
Improvestaple formation consistencyVSAvoidaccommodation of varying tissue thicknesses
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The driver is designed with a collapsible structure that allows it to change height dynamically during the stapling process. The driver includes a proximal portion and a distal portion connected by a hinge, enabling the distal portion to collapse relative to the proximal portion. This dynamic adjustment allows the driver to adapt to different tissue thicknesses, providing consistent staple formation across varying tissue conditions.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The driver is divided into multiple segments or portions (proximal portion and distal portion) that can move independently relative to each other. The hinge connection allows these segments to collapse together, reducing the overall driver height. This segmentation enables the driver to maintain a standard height for normal tissue thickness while collapsing to a reduced height for thicker tissue, thereby resolving the contradiction between consistency and adaptability.

Inventive Principle:
Principle #1Segmentation

2Device complexity

If a single driver height is used, then the device structure is simple, but it cannot accommodate both thin and thick tissues effectively

Engineering Contradiction:
Improvedriver structure simplicityVSAvoidtissue thickness accommodation
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

Rather than using multiple fixed-height drivers of different sizes, the invention employs a single driver with dynamic height adjustment capability. The collapsible mechanism allows the driver to transition between a first height for thin tissues and a second reduced height for thick tissues, maintaining device simplicity while achieving adaptability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The single collapsible driver serves multiple functions by adapting its height to match different tissue thicknesses. It can function as a standard-height driver for thin tissues and as a reduced-height driver for thick tissues, eliminating the need for multiple specialized drivers and simplifying the overall device structure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If excessive compressive force is applied to thick tissues, then the staple formation appears complete, but tissue damage such as necrosis and bleeding occurs

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

Solution Approach 1:

The collapsible driver adjusts its height dynamically based on tissue thickness, applying appropriate compressive force for each case. For thick tissues, the driver collapses to a reduced height, thereby reducing the compressive force applied to the tissue. This prevents excessive force that would cause necrosis or bleeding while still achieving complete staple formation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The driver height parameter is changed based on tissue thickness conditions. By collapsing the driver to a different height, the compressive force parameter is automatically adjusted. This parameter change ensures that the compressive force remains within a safe range that achieves staple formation without causing tissue damage.

Inventive Principle:
Principle #35Parameter changes

4Object-affected harmful factors

If the driver height is reduced for thick tissues, then tissue damage is prevented, but staple formation may be insufficient for thin tissues

Engineering Contradiction:
Improvetissue damage preventionVSAvoidstaple formation quality
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The driver's height is dynamically adjusted based on the tissue thickness encountered during stapling. For thin tissues, the driver maintains its full height to provide sufficient compressive force for proper staple formation. For thick tissues, the driver collapses to a reduced height to prevent excessive force and tissue damage. This dynamic adjustment resolves the contradiction between staple formation quality and tissue damage prevention.

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 system ensures consistent staple formation across varying tissue thicknesses, preventing tissue damage and improving surgical outcomes by adjusting staple height and force based on tissue conditions.

Implementation Method 1

using a cam mechanism to move the staple toward an anvil

Methodology Applied
Scientific EffectCam mechanism: Cam

Data Source

PatentUS11622785B2Surgical staples having attached drivers and stapling instruments for deploying the same
Publication Date: 2023.04.11 CILAG GMBH INTERNATIONAL
  • US11622785B2 patent drawing
  • US11622785B2 patent drawing
  • US11622785B2 patent drawing

AI summary

A staple cartridge comprising a cartridge body, staples, a first staple driver, a second staple driver, and a third staple driver is disclosed. The cartridge body comprises a knife slot and staple cavities defined in the cartridge body and arranged in an inner longitudinal row of staple cavities, a middle longitudinal row of staple cavities, and an outer longitudinal row of staple cavities on one side of the knife slot. The staples are removably stored within the staple cavities. The first staple driver is configured to eject a first quantity of staples from the staple cavities. The second staple driver is configured to eject a second quantity of staples from the staple cavities which is different than the first quantity of staples. The third staple driver is configured to eject a third quantity of staples that is the same as the first quantity of staples.