Expandable Backspan Surgical Staple for Tissue Thickness Adaptation

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Solution Overview

Problem

Current surgical staples are limited in accommodating varying tissue thicknesses, leading to ineffective hemostasis if the tissue thickness is misidentified or falls outside the range for a given staple size.

Innovation Solution

A surgical staple design featuring a backspan with crimped regions and a looped member that adjusts its configuration to accommodate different tissue thicknesses, ensuring effective hemostasis across a wider range of tissue thicknesses by altering the distance between its components based on tissue thickness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a surgical staple is designed with a fixed backspan configuration, then the manufacturing process is simple and cost-effective, but the staple can only accommodate a limited range of tissue thicknesses

Engineering Contradiction:
Improverange of tissue thicknesses accommodatedVSAvoidbackspan configuration
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The backspan is designed with an expandable configuration that transitions from a compressed delivery state to an expanded functional state. The distal ends of the backspan can spread apart to accommodate thicker tissue, providing adaptability while maintaining a compact form during delivery. This dynamic transformation allows a single staple design to handle multiple tissue thicknesses.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The backspan components are arranged in a nested or collapsed configuration during delivery, allowing the staple to maintain a compact profile. Upon deployment, the backspan expands outward to engage thicker tissue. This nesting principle enables the staple to achieve a larger functional dimension from a smaller delivered dimension, increasing versatility without proportionally increasing device complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If the clinician chooses a staple size based on estimated tissue thickness, then the procedure is quick and efficient, but ineffective hemostasis occurs if the thickness estimation is inaccurate

Engineering Contradiction:
Improvehemostasis effectivenessVSAvoidflexibility for varying tissue thicknesses
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The surgical staple is designed with a universal backspan configuration that can adapt to multiple tissue thickness categories (thin, medium, thick) within a single staple type. The expandable backspan allows the same staple design to effectively engage different tissue thicknesses, reducing the need for multiple specialized staple sizes and improving reliability across varying conditions.

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

Solution Approach 2:

The backspan's physical parameters (specifically the distance between distal ends) are designed to change based on tissue thickness requirements. The expandable structure allows the backspan to adjust its effective engagement width, changing from a narrow configuration for thin tissue to a wider configuration for thick tissue, thereby maintaining hemostasis effectiveness across different tissue types.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If multiple staple sizes are used to cover all tissue thickness ranges, then all tissue thicknesses can be accommodated, but the device selection becomes more complex and time-consuming

Engineering Contradiction:
Improvecoverage of tissue thickness rangesVSAvoidstaple selection process
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

By designing a universal staple with an expandable backspan, the system consolidates multiple specialized staple functions into a single multi-functional device. The clinician no longer needs to select from multiple staple sizes based on tissue thickness estimates; instead, a single staple type can adapt to various thicknesses, simplifying the selection process while maintaining comprehensive coverage.

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

Solution Approach 2:

The backspan is designed with excessive capacity to engage thicker tissue than the minimum required for thin tissue. This means the same backspan structure that provides sufficient engagement for thin tissue also has the capability to engage thicker tissue by expanding, thereby covering the full range of tissue thicknesses with a single design rather than requiring multiple precisely-tuned staple sizes.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentEP3482695B1Surgical staples with expandable backspan
Publication Date: 2023.03.22 COVIDIEN LP
  • EP3482695B1 patent drawingFigure 1~3
  • EP3482695B1 patent drawingFigure 4A~4C
  • EP3482695B1 patent drawingFigure 5

AI summary

A surgical staple includes a body includes a first leg, a second leg, and a backspan. The backspan has a first portion, a second portion, a third portion, and a crimped region. The first portion of the backspan includes a looped member. The second portion of the backspan extends between a first end portion of the first leg and a first end portion of the looped member. The third portion of the backspan extends between a first end portion of the second leg and a second end portion of the looped member. The crimped region includes a crimped section in at least one of the second portion or the third portion of the backspan. A combined wire thickness of the second and third portions of the backspan in the crimped region is about equal to the diameter of the body of the surgical staple.