Adjustable PDA Closure Device with Pivotable Flanges

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Solution Overview

Problem

Current treatments for closing patent ductus arteriosus in small premature infants are inadequate, with existing pharmacologic options showing low closure rates and significant adverse complications, and existing devices being unsuitable for infants under 6 months or less than 6 kg, due to their large size and invasive nature.

Innovation Solution

A ductus arteriosus closure device with adjustable body portions and pivotable flanges that can be delivered through a small catheter, allowing for precise placement and minimization of pressure on vascular tissues, comprising a distal annular flange, a body portion, and a proximal annular flange, which can be deployed to block or limit blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing PDA closure devices with large disc sizes are used, then effective closure can be achieved, but the devices cannot be delivered through small catheters and cause excessive pressure on vascular tissues

Engineering Contradiction:

Improveclosure effectivenessVSAvoidtissue pressure and delivery complexity

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device incorporates a body portion with adjustable length that can be dynamically configured to match the specific anatomy of each patient's ductus arteriosus. The flanges are designed to pivot from the longitudinal axis, allowing them to adapt to varying angles and minimize pressure on surrounding vascular tissues while maintaining effective closure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device allows for parameter adjustment including the length of the body portion which can be modified based on patient anatomy. The flanges can pivot to change their orientation relative to the body portion, enabling optimization of pressure distribution and delivery through small catheters while maintaining closure effectiveness.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If pharmacologic treatments such as indomethacin or ibuprofen are used, then closure can be achieved in some cases, but closure rates are low (around 60%) and toxic side effects occur including renal failure

Engineering Contradiction:

Improveclosure rateVSAvoidtoxic side effects

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces pharmacologic treatment with a mechanical device that physically blocks the ductus arteriosus. The device is delivered via catheter and positioned to obstruct blood flow through the ductus, providing a mechanical solution that avoids the toxic side effects of COX inhibitors while achieving closure through physical obstruction rather than chemical inhibition.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If surgical ligation is performed, then complete closure can be achieved, but the procedure is invasive and involves many associated complications

Engineering Contradiction:

Improveclosure completenessVSAvoidinvasiveness and complications

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces open surgical ligation with a percutaneous catheter-based device deployment. The device is inserted through a small catheter via the femoral vein or artery, avoiding the need for open chest surgery and direct manipulation of the heart, thereby reducing invasiveness and associated surgical complications while achieving complete closure through the mechanical obstruction provided by the device body.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If dehydration and diuretics are used, then blood flow through the ductus can be reduced, but closure rates are low and the defect often re-opens

Engineering Contradiction:

Improveclosure rateVSAvoidclosure durability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent replaces conservative medical management with a definitive mechanical closure device. The device provides sustained physical obstruction of the ductus arteriosus that does not rely on changing blood flow dynamics through dehydration, thereby achieving more reliable and durable closure that is less likely to reopen compared to temporary medical management.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS10932786B2Devices and methods for treating patent ductus arteriosus

Publication Date: 2021.03.02 CORVIA MEDICAL INC

AI summary

The present teachings provide a device to close a ductus arteriosus percutaneously. One aspect of the present teachings provides a device comprising at least one flange portion configured to be positioned against a vascular wall outside one end of a ductus arteriosus, and a body portion configured to be positioned inside the ductus arteriosus. The body portion of the device has a length adjustable in order for the device to fit inside patients with various ductus arteriosus lengths. The at least one flange portion of the device has pivotability in order for at least one flange to deflect from the longitudinal axis of the body portion so that the deployed device can be positioned at a treatment site allowing the discs to sit flat against the vascular tissue to promote closure while avoiding disruption of flow within the pulmonary artery and aorta or applying excess pressure to the surrounding vascular tissue. The body portion of the device could also at least partially block the ductus arteriosus, and thereby reduce or obstruct blood flow through the ductus arteriosus. The device includes a delivery profile and a deployment profile. Another aspect of the present teachings provides methods of using a device of the present teachings.