Septostomy Device Tissue Removal for Durable Interatrial Shunt

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Solution Overview

Problem

Current medical devices for creating interatrial shunts in the heart are temporary, prone to thrombosis, infection, and require blood-thinning medications, and are not capable of removing septum tissue to prevent aperture closure, with limited size range and direction control.

Innovation Solution

A septostomy device with a catheter assembly featuring a shaped blade and tissue retention mechanism that allows for precise cutting and removal of septum tissue to create a durable aperture, enabling adjustable shunt sizes and orientations without implants.

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 making the solution temporary

Engineering Contradiction:

Improveprocedure simplicityVSAvoidaperture durability

Core Design Contradiction:

Ease of manufactureVSDuration of action of stationary object

Solution Approach 1:

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

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of creating an opening and hoping it stays open, the invention inverts the approach by removing the separating tissue entirely. This inversion ensures the aperture remains open permanently, transforming a temporary solution into a durable one

Inventive Principle:

Principle #13The other way round (Inversion)

2Duration of action of stationary object

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

Engineering Contradiction:

Improveaperture durabilityVSAvoidthrombosis risk

Core Design Contradiction:

Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The invention removes the problematic stent implant entirely and replaces it with tissue removal. By extracting the separating tissue rather than implanting a stent, the solution eliminates thrombosis risk and the need for blood-thinning medications while maintaining aperture durability

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses a disposable, non-implantable approach where the septum tissue is removed and the aperture is created through tissue gap. This eliminates the need for permanent implants that cause thrombosis, using instead a temporary procedural solution that becomes permanent through tissue removal

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Stress or pressure

If a stent is implanted to control blood flow, then atrial pressure is reduced, but the implant is subject to infection and requires follow-on surgical treatments

Engineering Contradiction:

Improveatrial pressure controlVSAvoidinfection risk

Core Design Contradiction:

Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the stent implant and replaces it with direct tissue removal. This eliminates the foreign body that causes infection risk while maintaining the ability to control blood flow and reduce atrial pressure through the created aperture

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses a non-permanent, implant-free approach where the aperture is created through tissue removal rather than stent placement. This eliminates infection risk associated with permanent implants while achieving the same therapeutic effect of pressure reduction

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Quantity of substance

If the interatrial shunt is made large to ensure adequate blood flow, then flow control is improved, but oversized shunts can overload the right side of the heart

Engineering Contradiction:

Improveblood flowVSAvoidright heart overload

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The invention applies local quality by precisely controlling the size and location of the aperture through targeted tissue removal. The aperture dimensions are carefully controlled during the procedure to provide adequate blood flow while preventing right heart overload, creating a customized solution for each patient's needs

Inventive Principle:

Principle #3Local quality

5Ease of manufacture

If conventional devices are used to create interatrial shunts, then the procedure can be performed, but the devices are not capable of removing septum tissue to prevent aperture closure

Engineering Contradiction:

Improveprocedure feasibilityVSAvoidaperture permanence

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The invention incorporates tissue removal capability directly into the procedure, extracting a segment of the interatrial septum to create the aperture. This tissue removal ensures the aperture cannot close spontaneously, greatly improving reliability and permanence while maintaining procedural feasibility

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20220323094A1Method and septostomy device for creating an interatrial aperture

Publication Date: 2022.10.13 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.