Interatrial Septostomy Catheter for Controlled Tissue Removal

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing medical devices for creating interatrial shunts in the heart are temporary, prone to closure, cause thrombosis, require blood-thinning drugs, and may dislodge, leading to cardiac issues, while existing stent-type structures lack the ability to remove septum segments and control shunt size effectively.

Innovation Solution

A catheter-based septostomy system with expandable tissue retention devices and a cutting blade that creates or removes tissue to form a controlled interatrial aperture, allowing for precise shunt creation and removal of septum segments without implants, using visualization markers and actuators for precise control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a balloon is used to create a hole in the septum, then the procedure is simple and temporary, but the hole may spontaneously close over time

Engineering Contradiction:

Improveprocedure simplicityVSAvoidaperture permanence

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The invention extracts and removes a segment of the interatrial septum (fossa ovalis tissue) rather than merely creating a hole. By removing the tissue and creating a gap, the aperture becomes permanent and cannot spontaneously close, directly resolving the reliability issue while maintaining procedural simplicity

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of creating an opening and hoping it stays open (balloon method), the invention inverts the approach by removing the septal tissue to create the opening. This inversion ensures the aperture remains open permanently, as there is no tissue to heal and close the gap

Inventive Principle:

Principle #13The other way round (Inversion)

2Reliability

If a stent is implanted in the interatrial septum to keep the hole open, then the aperture remains open, but the implant promotes thrombosis and requires blood-thinning drugs

Engineering Contradiction:

Improveaperture opennessVSAvoidthrombosis risk

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The invention removes the problematic septal tissue segment entirely, eliminating the need for stent implants. By creating a gap through tissue removal rather than implanting a structure, the solution maintains aperture openness while eliminating thrombosis risks associated with foreign body implants

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses a temporary, non-implantable approach where the septal tissue is removed and the gap is created. This disposable-like approach (no permanent implant) eliminates long-term complications of stents while achieving the desired therapeutic effect

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Manufacturing precision

If a stent is implanted to control blood flow, then the shunt size can be controlled, but the implant may become dislodged and embolize causing cardiac damage

Engineering Contradiction:

Improveshunt size controlVSAvoidimplant stability

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The invention removes the septal tissue segment to create the shunt, eliminating the need for implanted stents that could dislodge. The shunt is created by the gap between the atrial chambers after tissue removal, which cannot become dislodged or embolize, directly resolving the stability issue while maintaining size control through the cutting mechanism

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention replaces the mechanical stent implant with a tissue removal mechanism. The shunt size is controlled by the dimensions of the gap created through tissue removal rather than by an implanted mechanical structure, eliminating the risk of implant dislodgement and embolization

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Quantity of substance

If the interatrial shunt is made large to ensure open flow, then blood flow is improved, but the shunt may overload the right side of the heart

Engineering Contradiction:

Improveblood flow volumeVSAvoidright heart overload

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The invention incorporates feedback mechanisms where the surgeon controls the size of the shunt gap through the cutting mechanism, and the body's hemodynamic response is monitored. The shunt size is adjusted to achieve adequate blood flow while preventing right heart overload, allowing for precise control of the flow-volume relationship

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS12471948B2Method and septostomy device for creating an interatrial aperture

Publication Date: 2025.11.18 INTERSHUNT TECHNOLOGIES INC

AI summary

A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.