Hybrid Capsule System for Cardiac Resynchronization Therapy
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Solution Overview
Problem
Conventional cardiac resynchronization therapy systems face challenges such as lead displacement, insulation issues, and the risk of bleeding or blood clots due to the need for physical connections and guidewires, particularly when targeting the left ventricle for stimulation, which limits the miniaturization and accessibility of cardiac resynchronization devices.
Innovation Solution
A hybrid capsule system with a miniaturized, wireless communication-enabled device and microleads for the left ventricle, combined with leadless capsules for the right ventricle and atrium, featuring a microcable with selectively exposed electrodes and a transition region of variable stiffness, eliminating the need for connectors and allowing for direct contact and anchoring, thereby simplifying implantation and reducing device size.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endocardial or coronary leads are used for left ventricle stimulation, then cardiac resynchronization therapy can be implemented, but the risk of lead displacement, insulation breakage, fibrosis, and bleeding increases
Solution Approach 1:
The patent extracts and eliminates the lead component from the system by implementing leadless capsules for both right and left ventricle stimulation. The left ventricle capsule is positioned in the left ventricular cavity without requiring coronary venous system access, thereby removing the source of lead-related complications while maintaining CRT functionality
Solution Approach 2:
The patent introduces a magnetic coupling mechanism as an intermediary for wireless power and data transmission between external devices and the implanted capsules. This eliminates the need for physical connectors and leads, reducing mechanical failure points and infection risks while enabling reliable therapy delivery
2Object-affected harmful factors
If leadless capsules are used for right ventricle and atrium stimulation, then lead-related complications are reduced, but the device size cannot be further miniaturized due to wireless communication requirements
Solution Approach 1:
The patent merges multiple functions into the leadless capsules: sensing, stimulation, wireless communication, and magnetic coupling all occur within a single miniaturized device. The integration of these functions eliminates the need for separate components and connectors, enabling further size reduction while maintaining leadless operation
Solution Approach 2:
The patent replaces mechanical connectors and lead-based signal transmission with electromagnetic fields for wireless communication and power transfer. This substitution eliminates the need for large mechanical interfaces and allows for significant miniaturization of the capsule form factor
3Ease of operation
If coronary leads are used to access the left ventricle, then left ventricular stimulation is achieved, but the device diameter cannot be reduced due to guidewire and connector requirements
Solution Approach 1:
The patent extracts the guidewire and connector components from the left ventricle access system by using a leadless capsule that is delivered via a simplified catheter-based approach. The capsule self-anchors in the left ventricular cavity without requiring coronary venous system navigation, enabling use of smaller delivery systems and reducing overall device diameter
Solution Approach 2:
Instead of accessing the left ventricle through the coronary venous system from the right side of the heart, the patent inverts the approach by delivering the left ventricle capsule through a different anatomical path that allows for smaller device dimensions and avoids the constraints of standard coronary lead delivery systems
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
This approach enables more reliable, miniaturized, and energy-efficient cardiac resynchronization therapy with reduced surgical complexity, improved safety, and compatibility with MRI exams, while allowing for smaller device diameters and reduced energy consumption.
Implementation Method 1
a microcable formed of an electrically conductive core cable connected to one pole of said electronic circuits with an insulation layer surrounding the core cable and including at least one selectively exposed area formed in the insulating layer to form a detection and/or stimulation electrode
Implementation Method 2
The at least one detection and/or therapy delivery microlead includes, in the proximal region of the microlead attached to the body of the hybrid capsule, a transition region of variable gradient stiffness, decreasing in the distal direction
Implementation Method 3
the seal body including at least a hermetic and electrically insulating bushing for the passage of the connection of the core cable of the microcable or of each microcable of each microcable, to a respective pole electronic circuits contained in the body of the hybrid capsule
Data Source
AI summary
A hybrid system forming an active implantable medical device includes a subcutaneous autonomous capsule and at least one intracorporeal autonomous leadless capsule. The subcutaneous capsule is a hybrid capsule having a seal body of dimensions comparable to those of a leadless capsule, but extended by a detection/stimulation microlead, without any intermediate connector. The leadless capsule includes a seal body, anchoring means in a wall of an organ and a detection/stimulation electrode. The hybrid capsule and the leadless capsules each include transmitter/receiver means for intracorporeal mutual wireless communication so as to constitute a network wherein the hybrid capsule is the master and leadless capsules are the slaves. The hybrid capsule further includes means for centralizing data transmitted by the leadless capsules and for exchanging data with remote external equipment.