RF Transcatheter Septal Excision for Durable Interatrial Shunting
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Solution Overview
Problem
Existing treatments for congestive heart failure, such as pharmacologic therapies and mechanical circulatory support, provide limited relief and are invasive, while implantable interatrial shunts pose risks of clotting and thrombosis, and temporary apertures like balloon atrial septostomy are not durable.
Innovation Solution
A transcatheter device assembly using RF energy-based tissue cutters creates a precisely-sized aperture between the right and left atria, employing an expandable tissue cutter and stabilizer to excise tissue efficiently and accurately, reducing left atrial pressure without an implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If implantable interatrial shunts are used to treat congestive heart failure, then left atrial pressure relief is achieved, but risks of clotting and thrombosis increase
Solution Approach 1:
The invention extracts the problematic implantable shunt device and replaces it with a transcatheter energy-based tissue cutter that creates an aperture without leaving a foreign body in the heart. The harmful implant is removed from the system entirely, eliminating the source of clotting and thrombosis risks while maintaining the therapeutic effect of left atrial pressure relief through the created aperture.
Solution Approach 2:
The invention replaces the mechanical implantable shunt system with an energy-based tissue cutting system. Instead of mechanically implanting a shunt device that requires physical presence in the heart, the system uses RF or laser energy to cut tissue and create an aperture, substituting mechanical implantation with energy-based tissue modification to eliminate thrombosis risks.
2Ease of manufacture
If traditional mechanical tissue cutting is used for interatrial anastomosis, then tissue excision is achieved, but surgical complexity and procedure time increase
Solution Approach 1:
The invention replaces traditional mechanical tissue cutting instruments with an energy-based tissue cutter that uses RF or laser energy. This substitution eliminates complex mechanical cutting mechanisms, reduces surgical instrumentation complexity, and simplifies the overall surgical procedure while maintaining effective tissue excision capability for interatrial anastomosis.
Solution Approach 2:
The invention changes the fundamental parameter of tissue cutting from mechanical force to energy application. By using RF or laser energy instead of mechanical blades or scissors, the system achieves tissue excision through thermal or electromagnetic parameters, thereby reducing mechanical complexity and simplifying the surgical procedure.
3Reliability
If balloon atrial septostomy is used to create interatrial aperture, then temporary pressure relief is achieved, but durability is insufficient
Solution Approach 1:
The invention performs preliminary tissue excision using an energy-based cutter to create a permanent aperture before any stent or support structure is deployed. By pre-cutting the tissue with RF or laser energy, the system establishes a durable opening that is not dependent on balloon inflation or temporary mechanical support, thereby ensuring long-term durability of the interatrial communication.
Solution Approach 2:
The invention replaces the balloon-based temporary aperture creation with an energy-based permanent tissue cutting system. Instead of relying on mechanical balloon inflation that deflates and loses effectiveness, the system uses RF or laser energy to permanently modify the tissue structure, creating a durable aperture that maintains pressure relief effect long-term.
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 achieves a durable, minimally invasive method to create a controlled interatrial shunt, effectively lowering left atrial pressure and improving cardiac mechanics with reduced risk of complications.
Implementation Method 1
the energy is in the range of radio frequency (RF) spectrum
Implementation Method 2
employing an expandable tissue cutter and stabilizer to excise tissue efficiently and accurately
Data Source
AI summary
The present disclosure relates to a device assembly and a method for treating heart failure by normalizing elevated blood pressure in the left atrium of a heart of a mammal. Disclosed herein is a RF energy-based transcatheter interatrial septum excision device configured to create a sized interatrial aperture between the right and left atria of a heart for the relief of elevated left atrial pressure. The device assembly comprises a delivery catheter, a tissue stabilizer attached to a tissue stabilizer catheter, a tissue cutter attached to a tissue cutter catheter, a remotely located RF generator connected to an RF cathode and anode of the device assembly.