Segmented Catheter for Renal Neuromodulation
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Solution Overview
Problem
Current therapies for hypertension, heart failure, chronic kidney disease, insulin resistance, and diabetes are inadequate due to issues like non-compliance and varying responses, and there is a need for a catheter that can effectively deliver energy to renal sympathetic nerves within the renal artery while navigating its unique anatomy and maintaining stable contact during blood flow and respiratory motion.
Innovation Solution
A catheter system with an elongated shaft featuring flexible zones and a thermal heating element designed to navigate the renal artery, maintain contact with the vessel wall, and deliver energy for neuromodulation, including thermal and electrical energy, to reduce sympathetic renal nerve activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a catheter is used to deliver energy to renal sympathetic nerves from within the renal artery, then the treatment can be performed minimally invasively, but the catheter must navigate the unique renal artery anatomy while maintaining stable contact during blood flow pulsatility and respiratory motion
Solution Approach 1:
The catheter shaft is divided into multiple sections with different mechanical properties: a proximal stiff section for navigation and control, and a distal flexible section for stable contact with the vessel wall. This segmentation allows the catheter to navigate tortuous renal artery anatomy while maintaining reliable energy delivery contact despite blood flow pulsatility and respiratory motion.
Solution Approach 2:
The catheter incorporates a flexible distal section that can dynamically adapt to the moving renal artery wall during cardiac cycles and respiratory motion. This dynamic flexibility allows the energy delivery element to maintain stable contact with the vessel wall while the artery undergoes physiological movements, ensuring reliable neuromodulation treatment.
2Adaptability or versatility
If the catheter is made flexible to navigate the renal artery, then navigation is improved, but the ability to maintain stable contact with the vessel wall during energy delivery may be compromised
Solution Approach 1:
The catheter is constructed with segmented shafts having different stiffness characteristics. The proximal shaft provides structural support for precise navigation and positioning, while the distal shaft offers flexibility to conform to the renal artery geometry. This segmentation resolves the contradiction between navigation adaptability and contact stability by assigning different functional requirements to different sections.
Solution Approach 2:
Different portions of the catheter are designed with locally optimized mechanical properties. The proximal section has higher stiffness for precise control and navigation, while the distal section has lower stiffness for flexible contact with the vessel wall. This local quality differentiation allows the catheter to simultaneously achieve good navigation capability and stable energy delivery contact.
3Adaptability or versatility
If current therapies are used for hypertension and related conditions, then treatment options are available, but control of blood pressure and prevention of disease progression remain unsatisfactory due to non-compliance and heterogeneity in responses
Solution Approach 1:
The invention replaces pharmacological treatment (chemical system) with a device-based neuromodulation approach (mechanical/electrical system). By using a catheter to deliver electrical or thermal energy directly to the renal sympathetic nerves, the treatment achieves more reliable and controllable blood pressure control without the issues of medication non-compliance and heterogeneous drug responses.
Solution Approach 2:
The invention changes the fundamental treatment parameter from pharmacological dosage to physical energy delivery (electrical or thermal). This parameter change enables more precise control of therapeutic effect through adjustable energy delivery parameters, improving reliability of blood pressure control and allowing customization to individual patient needs while eliminating compliance issues associated with oral medications.
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 system enables precise and stable energy delivery to the renal plexus, effectively reducing sympathetic nerve activity, thereby addressing the inadequacies of current therapies for the mentioned conditions.
Implementation Method 1
application of thermal and/or electrical energy
Implementation Method 2
thermal alteration
Implementation Method 3
irreversible electroporation
Implementation Method 4
electrofusion
Implementation Method 5
ablation
Data Source
AI summary
Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a catheter treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver an energy delivery element to a renal artery via an intravascular path. Thermal or electrical renal neuromodulation may be achieved via direct and/or via indirect application of thermal and/or electrical energy to heat or cool, or otherwise electrically modulate, neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.