PFO Closing Device Using Resorbable Suture and Catheter Clamping

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Solution Overview

Problem

Conventional PFO closing devices using percutaneous catheterization face challenges in securely joining septum primum and septum secundum due to anatomical variations, often resulting in foreign body reactions and potential thrombosis, and require complex procedures with invasive methods.

Innovation Solution

A PFO closing device with a needle part and clamping member mounted in a catheter for easy protrusion and retraction, allowing for precise tissue clamping and energy application to join tissues without leaving foreign materials, using a simple configuration that adapts to individual anatomical differences.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional disk-like membrane or anchor member is used for closing PFO, then the defect can be closed, but foreign body reactions occur and thrombi are liable to deposit

Engineering Contradiction:
ImprovePFO closure effectivenessVSAvoidforeign body reaction and thrombosis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and eliminates the foreign body (disk-like membrane or anchor member) from the closure system. Instead of using a permanent implant, the invention uses a resorbable suture that is completely absorbed by the body, removing the source of foreign body reactions and thrombosis while maintaining effective PFO closure through tissue bonding.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention employs a resorbable suture that is designed to be temporary and short-lived in the body. The suture performs its function of closing the PFO during the critical healing period and then is completely broken down and absorbed by the body, eliminating the need for permanent foreign materials that cause adverse reactions.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Ease of operation

If percutaneous catheterization is used for PFO closure, then the procedure is less invasive, but it is difficult to securely join septum primum and septum secundum due to anatomical variations

Engineering Contradiction:
Improveprocedural invasivenessVSAvoidtissue joining security
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention changes the physical and chemical parameters of the joining mechanism. Instead of mechanical clamping that relies on precise positioning, the invention uses a resorbable suture with specific tensile strength and degradation characteristics that adapts to anatomical variations. The suture can be tied with appropriate tension and will maintain closure while healing occurs, regardless of slight variations in septal anatomy.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If open heart surgery with extracorporeal circulation is used, then PFO closure is more assured, but the procedure is highly invasive with significant risks

Engineering Contradiction:
ImprovePFO closure assuranceVSAvoidprocedural invasiveness and risk
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention extracts and removes the need for extracorporeal circulation and open chest surgery. By using a percutaneous approach with a resorbable suture, the procedure achieves reliable PFO closure without requiring heart-lung machine support or sternotomy, dramatically reducing procedural invasiveness and associated risks while maintaining closure effectiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

4Stability of the object's composition

If conventional clamping devices are left indwelling in the patient's body, then the PFO remains closed, but positional deviation may occur and thrombi may deposit

Engineering Contradiction:
ImprovePFO closure stabilityVSAvoidthrombosis and positional deviation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The invention removes the indwelling foreign body from the system by using a resorbable suture that is temporarily present to achieve closure and then completely disappears after serving its purpose. This eliminates the ongoing risks of thrombosis and positional deviation associated with permanent implants while maintaining closure stability during the critical healing period.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention performs the closure action preliminarily during the procedure using the suture, and the suture is designed to maintain closure stability during the healing process. Once healing is complete, the suture has fulfilled its preliminary function and is absorbed, having provided stable closure without requiring long-term presence in the body.

Inventive Principle:
Principle #10Preliminary action

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 device ensures accurate, speedy, and easy closure of PFO by minimizing blood leakage and avoiding foreign body reactions, enhancing safety and reducing procedural complexity.

Implementation Method 1

clamping means having a needle part for puncturing the SP, and a clamping member for cooperating with the needle part in clamping therebetween the tissues including the SP and the SS

Methodology Applied
Scientific EffectMechanical Force: Force

Implementation Method 2

energy supplying means for supplying energy for joining the tissues clamped by the needle part and the clamping member

Methodology Applied
Scientific EffectEnergy supply for joining:

Data Source

PatentEP2368510B1PFO closing device
Publication Date: 2015.07.01 TERUMO KK
  • EP2368510B1 patent drawingFigure 1
  • EP2368510B1 patent drawingFigure 2
  • EP2368510B1 patent drawingFigure 3~5

AI summary

The present invention provides a PFO closing device for bringing septum primum and septum secundum into contact and joint with each other. The device includes clamping means and energy supplying means. The clamping means includes a needle part for puncturing the septum primum, and a clamping member for cooperating with the needle part in clamping therebetween the tissues having the septum primum and the septum secundum. The energy supplying means supplies energy for joining the tissues clamped by the needle part and the clamping member. The clamping means is mounted in a catheter so as to be protrudable from and retractable into the catheter.