Magnetic Compression Shunt Device for Controlled Cardiac Decompression
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Solution Overview
Problem
Existing cardiac shunt devices are often hazardous, cause sudden pressure changes leading to heart failure, and require long-term anticoagulant medication, while also being permanently implanted and lacking dynamic control over fluid flow.
Innovation Solution
A shunt device using a shape memory alloy wire that transforms into a coil shape with magnets to create a controlled shunt, allowing for gradual decompression and dynamic fluid control without the need for permanent implantation or long-term medication, utilizing a delivery system that deploys the device through a minimally invasive catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a piercing tip is used to create a shunt, then the shunt can be formed quickly, but it causes injury to adjacent organs and requires long-term anticoagulant medication
Solution Approach 1:
The patent replaces the mechanical piercing tip with a magnetic compression system. Magnets are positioned on opposite sides of the tissue to be treated, and magnetic attraction forces compress the tissue between them, creating a shunt without physical penetration. This substitution eliminates the harmful mechanical piercing action while maintaining shunt formation capability.
2Productivity
If a shunt is created instantaneously, then the procedure is faster, but it causes sudden increase in pressure and work-load on the heart which could result in acute heart failure
Solution Approach 1:
The magnetic compression system applies force gradually over time rather than instantaneously. The magnets can be positioned and activated in a controlled sequence, allowing the tissue to adapt progressively to the changing pressure conditions. This periodic or gradual action prevents sudden pressure changes that could cause acute heart failure.
3Duration of action of stationary object
If a permanently implanted device is used to maintain shunt, then the shunt remains open, but it creates the need for long-term antiplatelet and anti-coagulant medication
Solution Approach 1:
The magnetic compression system uses temporary magnets that can be removed after the shunt is formed. Once the tissue has healed and the shunt is established, the magnets are discarded or recovered, eliminating the need for long-term implanted devices and the associated requirement for anticoagulant medication.
4Volume of moving object
If a small profile device is used for minimally invasive delivery, then the delivery is easier, but it may not exert sufficiently high compressive force to create a shunt
Solution Approach 1:
The system uses pairs of magnets positioned on opposite sides of the tissue, with each magnet contributing to the compressive force. The magnetic attraction between the paired magnets creates concentrated compressive force at the tissue interface, enabling high local pressure despite the small overall device profile.
5Ease of operation
If magnetic forces alone are used for orientation and positioning, then the device can be delivered minimally invasively, but it may lack sufficient control for correct positioning
Solution Approach 1:
The patent introduces additional positioning mechanisms as intermediaries to assist with device orientation and placement. These may include mechanical guides, delivery catheters with positioning features, or imaging guidance systems that work in conjunction with the magnetic forces to achieve precise positioning while maintaining minimally invasive delivery.
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 safely creates a shunt with controlled decompression and fluid flow management, reducing the risk of heart failure and eliminating the need for long-term anticoagulant medication, while being removable and deployable through a minimally invasive procedure.
Implementation Method 1
a wire comprised of a shape memory alloy, wherein the wire is adapted to transform from a substantially straight wire to a coil shape upon heating
Implementation Method 2
a plurality of magnets coupled to the at least two inner loops, wherein the plurality of magnets are adapted to provide a compressive force to adjacent inner loops of the wire in the coil shape
Data Source
AI summary
A shunt device for creating a shunt in an atrial septum includes magnets coupled to inner loops of a coil comprising at least two inner loops and two outer loops, with a diameter of each of the inner loops being less than a diameter of the outer loops. The coil is made of a shape memory alloy (SMA) and is adapted to exert a compressive force upon layers of tissue caught between the inner loops of the coil. The magnets are adapted to provide additional compressive force to adjacent inner loops of the coil, thereby further causing the coil to cut through the layers of tissue and create a shunt. The diameter of the resultant shunt is less than the diameter of the outer loops, thereby preventing the outer two loops from passing through the created shunt. At least one end of the coil has a connection means for connecting with a delivery device.