Atrial Shunt Stability via Balloon Thermal Isolation
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Solution Overview
Problem
Current atrial shunting procedures face challenges in maintaining the effectiveness of the shunt due to tissue regrowth and blood flow warming the septal tissue during ablation, which reduces the longevity of the created pathway between the right and left atria.
Innovation Solution
A method involving a balloon-based ablation device that thermally isolates the atrial septum from blood flow using refrigerant and radiofrequency energy, with a unique balloon design featuring longitudinally spaced lobes and angled spray ports to deliver ablation energy effectively, preventing tissue warming and promoting a stable shunt.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a stent is left in place to prevent tissue regrowth and maintain the shunt, then the shunt stability is improved, but the device complexity and risk of thrombus formation increase
Solution Approach 1:
The patent removes the stent from the procedure entirely, using only ablation energy to create and maintain the shunt. The ablation creates a permanent scar that prevents tissue regrowth without requiring any mechanical support structure to remain in the body, thereby eliminating device complexity and thrombus risks associated with stents.
Solution Approach 2:
The patent replaces the mechanical stent support system with a thermal ablation system. Instead of using a physical structure to maintain the shunt opening, the procedure uses controlled thermal energy to create irreversible tissue damage that permanently prevents tissue regrowth, substituting a mechanical solution with a thermal/chemical one.
2Ease of manufacture
If cryogenic energy is delivered to ablate the septal wall without thermal isolation, then the ablation process is simpler, but blood flow warms the tissue reducing ablation effectiveness and shunt longevity
Solution Approach 1:
The patent introduces a thermal insulating barrier (such as a balloon or protective coating) as an intermediary between the blood and the ablation site. This barrier prevents heat transfer from the warm blood to the cryogenically ablated tissue, maintaining the effectiveness of the ablation and ensuring long-term shunt patency without complicating the overall procedure.
Solution Approach 2:
The patent creates a thermally inert environment around the ablation site by introducing thermal insulation that isolates the cryogenically treated tissue from the warm blood flow. This inert thermal environment protects the ablated tissue from rewarming, ensuring the durability of the shunt creation.
3Reliability
If mechanical devices are used to maintain the shunt, then the shunt patency is improved, but the risk of thrombus formation and device-related complications increases
Solution Approach 1:
The patent removes all mechanical devices from the shunt maintenance process, relying solely on the ablation-induced scar tissue to prevent recurrence. By eliminating foreign bodies from the heart, the procedure naturally eliminates the thrombus formation risk associated with mechanical devices while maintaining effective shunt patency through the permanent tissue alteration.
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 solution effectively maintains the atrial shunt by preventing tissue regrowth and ensuring the longevity of the blood flow pathway between the atria, enhancing the procedure's effectiveness and reducing the need for mechanical devices to maintain the shunt.
Implementation Method 1
The balloon is inflated and configured to thermally isolate the atrial septum from blood within the left atrium and the right atrium
Implementation Method 2
delivering refrigerant to the balloon includes spraying refrigerant to a middle portion of the balloon
Implementation Method 3
delivering ablation energy to ablate the atrial septum includes delivering radiofrequency energy
Implementation Method 4
delivering ablation energy to ablate the atrial septum includes delivering radiofrequency energy
Implementation Method 5
delivering refrigerant to the balloon includes spraying refrigerant to a middle portion of the balloon
Implementation Method 6
spraying refrigerant to a middle portion of the balloon
Data Source
AI summary
A method of creating a shunt between a right atrium and a left atrium of a mammalian heart including puncturing an atrial septum between the right atrium and the left atrium to create a shunt. An ablation device having balloon is advanced at least partially through the shunt. The balloon is inflated and configured to thermally isolate the atrial septum from blood within the left atrium and the right atrium. Ablation energy is delivered to ablate the atrial septum.