Super Elastic Loop Extraluminal Anastomosis Delivery Instrument

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Solution Overview

Problem

Current surgical methods for forming anastomosis often result in leakage of bodily fluids and tissue necrosis due to incomplete sealing or suturing, necessitating a system for applying sealants or adhesives externally to facilitate healing and deliver medicaments to the anastomosis site.

Innovation Solution

A materials delivery instrument featuring a super elastic wire that transforms from a straight to a loop configuration, allowing for the extraluminal delivery of treatment materials such as adhesives or medicaments around the circumference of anastomotic sites, using an elongate tube with a treatment lumen and an outer sheath to control the wire's stress state and facilitate even application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fasteners are applied within the lumen to rejoin tubular tissue sections, then the tissue sections can be secured together, but leakage of bodily fluids through gaps in the anastomosis can occur

Engineering Contradiction:
Improvesealing integrityVSAvoidfluid leakage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention inverts the traditional approach by applying fasteners and sealants from the extraluminal side rather than the intraluminal side. The catheter delivers sealant and fasteners to the external surface of the anastomosis, allowing sealing without compromising the internal lumen and preventing fluid leakage through the tissue walls.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The invention introduces a catheter as an intermediary delivery system that transports sealant and fasteners from the operator to the anastomotic site. This intermediary enables precise placement of sealing materials on the external surface, ensuring reliable sealing while avoiding direct manipulation within the lumen.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If staples or sutures are used to join tissue sections, then the tissue can be secured together, but necrosis or death of substantial amounts of stapled or sutured tissue may occur before healing

Engineering Contradiction:
Improvetissue bondingVSAvoidtissue necrosis
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention changes the parameters of tissue joining by using a combination of sealant material and fasteners applied in sequence. The sealant is first applied to create a protective barrier, then fasteners are applied to secure the tissue. This parameter change in the joining process maintains tissue strength while preventing necrosis by avoiding excessive mechanical compression.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention applies sealant material beforehand to cushion and protect the tissue before fasteners are applied. This prior cushioning layer prevents direct tissue contact with the fasteners, reducing the risk of necrosis while maintaining adequate bonding strength for tissue healing.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Adaptability or versatility

If a preformed loop of super elastic material is used for extraluminal delivery, then treatment material can be applied to the circumference of the anastomosis, but the instrument complexity increases

Engineering Contradiction:
Improvecircumferential application capabilityVSAvoidinstrument structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The invention uses a preformed loop of super elastic material that dynamically changes shape during deployment. The loop is compressed into a linear configuration for catheter insertion, then expands to its circular form at the anastomotic site. This dynamic transformation enables circumferential application capability without requiring a permanently complex instrument structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention employs a flexible super elastic material for the loop structure that can be compressed and expanded. This flexible material allows the instrument to be delivered through a narrow catheter in a linear form and then expand to a circular configuration for circumferential treatment material application, reducing overall instrument complexity.

Inventive Principle:
Principle #30Flexible shells and thin films

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 instrument effectively seals and delivers treatment materials to the entire circumference of anastomotic sites, reducing leakage and promoting healing by ensuring comprehensive application of adhesives or medicaments, thereby enhancing the integrity and completeness of the anastomosis.

Implementation Method 1

A super elastic wire is positioned within a distal end of the instrument. The super elastic wire has a straight configuration in a stressed condition and a loop configuration in the unstressed condition

Methodology Applied
Scientific EffectSuper elasticity: Pseudoelasticity

Implementation Method 2

An outer sheath is movably positioned over the instrument such that the super elastic wire is in the stressed condition when retracted into the sheath and in the unstressed condition when the instrument is extended beyond a distal end of the sheath

Methodology Applied
Scientific EffectMechanical constraint: Physical Containment

Data Source

PatentUS10039533B2Super elastic loop extraluminal materials delivery instrument
Publication Date: 2018.08.07 COVIDIEN LP
  • US10039533B2 patent drawing
  • US10039533B2 patent drawing
  • US10039533B2 patent drawing

AI summary

A materials delivery instrument is provided and includes an outer sheath and an instrument movably mounted within the outer sheath. The instrument includes a treatment lumen extending substantially the length of the instrument for receipt of treatment material. A super elastic wire is positioned in at least a distal end of the instrument. The super elastic wire forms a loop in an unstressed state to allow the instrument to encircle an anastomosis formed between a pair of tubular tissue sections. The super elastic wire is in a stressed state when the instrument is retracted within the outer sheath and in the unstressed state when the instrument is extended from the outer sheath to enclose the anastomosis. A proximal end of the super elastic wire is oriented substantially perpendicular to a plane formed by the loop to allow the instrument to lie parallel to the tubular tissue sections during the spraying of the anastomosis. A source of air pressure may be provided through the instrument to facilitate spraying the treatment material onto the anastomosis.