Renal Denervation Balloon Catheter with Ride-Along Electrode Support
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Solution Overview
Problem
Current medical devices for renal nerve ablation lack effective methods for targeted and controlled energy delivery to treat conditions like hypertension without damaging neighboring nerves or tissues.
Innovation Solution
A medical device with a catheter shaft and an expandable member, featuring a flexible elongate electrode assembly and electrode elements that can expand and collapse, allowing for precise energy delivery to renal nerves without direct contact, using a control unit for energy management and tissue assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If direct contact between electrode and renal nerves is required for effective ablation, then energy delivery effectiveness is improved, but risk of damage to neighboring nerves and tissues increases
Solution Approach 1:
An expandable balloon is introduced as an intermediary between the electrode and the renal nerves. The balloon expands to press the electrode elements against the vessel wall, ensuring effective energy delivery while controlling the contact area to prevent damage to surrounding tissues. This mediator allows controlled, localized ablation without requiring direct manipulation of the electrode against the nerves.
Solution Approach 2:
The electrode elements are configured to deliver energy locally at specific contact points with the vessel wall. By expanding the balloon, the electrode elements make localized contact only where needed, concentrating energy delivery to the renal nerves while leaving surrounding tissues unaffected. This localizes the therapeutic effect and minimizes collateral damage.
2Stability of the object's composition
If expandable member and electrode support are attached together, then structural stability is improved, but ability to independently collapse and withdraw components is worsened
Solution Approach 1:
The device is segmented into two main components: an expandable balloon and a separate electrode support structure. The electrode support includes flexible elongate members that can independently collapse and be withdrawn from the balloon. This segmentation allows the balloon to be deflated and removed first, followed by withdrawal of the electrode support, simplifying the overall withdrawal process and reducing complications.
Solution Approach 2:
The electrode support structure incorporates flexible elongate members that can dynamically change configuration. During delivery, the structure is constrained within the balloon; during the procedure, it expands to provide stable electrode positioning; during withdrawal, the members can compress and flex to navigate the catheter shaft. This dynamic adaptability allows the structure to maintain stability when needed while enabling easy withdrawal when required.
3Manufacturing precision
If electrode elements are fixed rigidly, then positioning precision is improved, but flexibility for navigation and adaptation to vessel geometry is worsened
Solution Approach 1:
The electrode elements are constructed using flexible materials and thin-film structures that can bend and conform to the curvature of the renal artery. These flexible electrode elements maintain precise positioning when the balloon is expanded, as the balloon provides a stable platform, while still allowing the catheter to navigate through tortuous vasculature during delivery. The flexibility is achieved through materials and structures that can deform without compromising electrical contact or structural integrity.
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
Enables non-invasive, precise ablation of renal nerves, reducing blood pressure effectively while minimizing damage to surrounding tissues and avoiding the need for exact contact, allowing for controlled energy dosage and tissue remodeling.
Implementation Method 1
an expandable member coupled to the catheter shaft... the electrode support capable of expanding with the expandable member
Implementation Method 2
energizing the electrode assemblies... precise ablation of renal nerves... controlled energy dosage
Data Source
AI summary
A renal nerve ablation device may include an elongate tubular member having a distal region. An expandable member may be coupled to the distal region. An electrode support may be coupled to the distal region of the elongate tubular member and extend over a body of the expandable member. The electrode support may be free of connection to the body of the expandable member. One or more electrodes may be coupled to the electrode support.