Suture-Based PFO Closure Device

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Solution Overview

Problem

Conventional occluders for atrial septal defects, such as PFOs, pose challenges due to their braided or metallic construction, which can complicate surgical access, interfere with MRI imaging, and cause tissue erosion or nickel allergies, necessitating an alternative closure method.

Innovation Solution

A suture device with an operational shaft housing an anchor assembly and needle assembly, deployed through a PFO to secure a suture, allowing for closure without metallic components, using a steerable catheter and suture trimmer for precise placement and tensioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional braided or metallic occluders are used to close ASDs, then the defect closure function is achieved, but surgical access is complicated and device removal or reoperation becomes more difficult

Engineering Contradiction:

Improvedefect closure functionVSAvoidsurgical access and device removal

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent extracts the harmful metallic and braided components from the occluder design, retaining only the essential suture material that can be easily manipulated and removed. The occluder is reduced to a simple suture that can be passed through the defect and tied, eliminating the complexity of metallic frames and braided structures that complicate surgical access and removal.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs a simple, disposable suture material that serves its purpose of closing the defect and can be easily removed or left to dissolve, rather than using permanent metallic implants that require complex removal procedures. This approach prioritizes ease of operation over long-term permanence.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Strength

If metallic frame occluders are implanted to close ASDs, then structural support is provided, but MRI imaging is interfered with and diagnostic accuracy is reduced

Engineering Contradiction:

Improvestructural supportVSAvoidMRI imaging capability

Core Design Contradiction:

StrengthVSDifficulty of detecting and measuring

Solution Approach 1:

The patent removes all metallic components from the occluder design, using only non-magnetic suture material that does not interfere with MRI imaging. The structural support function is achieved through the tension and configuration of the suture itself rather than through a metallic frame, eliminating the conflict between structural support and imaging compatibility.

Inventive Principle:

Principle #2Taking out (Extraction)

3Duration of action of stationary object

If nitinol or metallic frame devices are used for ASD closure, then device durability is ensured, but tissue erosion and allergy risks increase

Engineering Contradiction:

Improvedevice durabilityVSAvoidtissue erosion and allergy risks

Core Design Contradiction:

Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent extracts all nitinol and metallic components from the occluder, using only biocompatible suture material that eliminates the risk of nickel allergies and tissue erosion associated with metallic implants. The durability function is achieved through the strength and knot security of the suture material rather than through metallic durability.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses homogeneous biocompatible material throughout the occluder construction, eliminating the interface between different materials (metallic frame and tissue) that can cause erosion and allergic reactions. The entire device is composed of compatible suture material that the body can tolerate without adverse reactions.

Inventive Principle:

Principle #33Homogeneity

4Reliability

If complex braided occluders are implanted to close ASDs, then defect sealing is achieved, but future surgical access to atria is limited or made more difficult

Engineering Contradiction:

Improvedefect sealingVSAvoidfuture surgical access

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent removes the complex braided structure that obstructs future surgical access, using only a simple suture that can be easily manipulated and removed when future access is needed. The defect sealing function is achieved through the suture knot and tension rather than through a complex braided mesh structure.

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20230210520A1Defect closure system and methods of operation thereof

Publication Date: 2023.07.06 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A method of closing a patent foramen ovale (PFO) including a septum primum and septum secundum is implemented using a suture device including an operational shaft housing an anchor assembly, a needle assembly, and a suture. The method includes advancing an end of the operational shaft to a proximal side of the PFO, positioning a distal portion of the end of the operational shaft on a distal side of the PFO, and actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO. The method also includes actuating the needle assembly on the proximal side of the PFO to deploy the needle assembly through the PFO and the anchor assembly, thereby deploying the suture through the PFO. The method further includes retracting the anchor assembly into the operational shaft, and withdrawing the distal portion of the operational shaft from the PFO, leaving the deployed suture.