Renal Nerve Modulation Catheter with Perimeter Therapeutic Elements
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Solution Overview
Problem
Current pharmacologic strategies for managing excessive renal sympathetic activation, such as hypertension and heart failure, have limitations including limited efficacy, compliance issues, and side effects, necessitating alternative approaches for modulating renal nerves.
Innovation Solution
A neuromodulation catheter system that includes a distal portion with therapeutic elements arranged around its perimeter, allowing for the delivery of chemical agents to modulate renal nerve activity by positioning the catheter in a renal vessel and orienting therapeutic elements to extend through the vessel wall, enabling targeted delivery to adjacent nerves in multiple renal vessels simultaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacologic strategies (centrally-acting sympatholytic drugs, beta blockers, ACE inhibitors, diuretics) are used to manage excessive renal sympathetic activation, then renal nerve activity can be modulated, but efficacy is limited and side effects occur
Solution Approach 1:
The patent extracts the modulation action from systemic pharmacologic agents and delivers it locally at the renal nerve site through catheter-based therapeutic elements. This extraction of the therapeutic action from systemic circulation to localized delivery at the target site eliminates the side effects associated with systemic drug administration while maintaining efficacy in modulating renal sympathetic activity.
Solution Approach 2:
The patent introduces a catheter system with therapeutic elements as an intermediary between the operator and the renal nerves. This intermediary device enables direct, localized delivery of neuromodulation agents to the renal nerve plexus, bypassing the need for systemic pharmacologic intervention and its associated side effects.
2Reliability
If pharmacologic strategies are used to modulate renal sympathetic activity, then renal nerve function can be influenced, but compliance issues arise
Solution Approach 1:
The patent extracts the chronic daily medication requirement and replaces it with a single procedural intervention using a catheter system. By delivering the therapeutic effect through a one-time or limited-number procedure rather than requiring ongoing patient compliance with daily medication regimens, the system eliminates compliance issues while maintaining therapeutic efficacy.
3Adaptability or versatility
If therapeutic elements are oriented toward multiple renal vessels simultaneously, then coverage of adjacent nerves in multiple vessels is achieved, but device complexity increases
Solution Approach 1:
The patent designs the catheter system with multiple therapeutic elements that can be oriented toward multiple renal vessels simultaneously, making the device universal for treating various renal vascular anatomies. This multi-functional capability allows a single catheter design to handle different patient anatomies and treatment scenarios without requiring multiple specialized devices.
Solution Approach 2:
The patent divides the catheter into multiple independent therapeutic elements arranged around the perimeter, each capable of independent orientation and deployment. This segmentation allows selective activation and orientation of specific elements toward specific vessels, simplifying the control of complex multi-vessel treatments by treating each vessel segment independently.
4Measurement precision
If imaging is used to visualize positions of therapeutic elements, then positioning accuracy is improved, but procedure time increases
Solution Approach 1:
The patent incorporates radiopaque markers or imaging-visible features on the therapeutic elements that allow visualization under standard fluoroscopic or angiographic imaging. These visual indicators enable rapid assessment of therapeutic element positioning without requiring complex imaging sequences or prolonged imaging time, thus maintaining positioning accuracy while minimizing procedure time.
Data Source
AI summary
A method may include positioning a distal portion of a neuromodulation catheter in a first renal vessel of a patient. The distal portion may include a plurality of therapeutic elements arranged around a perimeter of the distal portion. The method also may include imaging the distal portion to visualize positions of the plurality of therapeutic elements; manipulating the distal portion so that at least one therapeutic element is oriented toward a second renal vessel adjacent the first renal vessel; deploying the at least one therapeutic element to extend at least partially through the wall of the first renal vessel such that the at least therapeutic element extends toward the second renal vessel; and delivering a chemical agent through the plurality of therapeutic elements to modulate activity of at least one renal nerve adjacent to the first renal vessel and at least one renal nerve adjacent to the second renal vessel.