Catheter Shaping Structure for Renal Neuromodulation
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Solution Overview
Problem
Current RF-based renal therapy catheters face challenges with positioning electrodes within vessels and maintaining uniform contact, leading to issues with outside diameter and distal tip flexibility, which complicates the treatment of conditions like congestive heart failure and renal failure.
Innovation Solution
A catheter apparatus with an elongate shaft and a moveable shaping structure that transitions between delivery and deployed states, featuring a deployment member with a guidewire and reinforcing material, allowing for precise placement and stable contact with the renal artery wall, reducing the risk of stenosis formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a catheter is designed with a larger outside diameter to accommodate positioning and contact maintenance mechanisms, then electrode positioning precision and contact stability improve, but catheter flexibility and ease of insertion deteriorate
Solution Approach 1:
The shaping structure is nested within the catheter shaft during delivery, allowing the catheter to maintain a small profile for easy insertion while housing the electrode positioning mechanism. The shaping structure can be deployed from the catheter shaft to provide structural support and maintain contact stability during the procedure.
Solution Approach 2:
The catheter employs a dynamic shaping structure that can transition between compressed and expanded states. During insertion, the shaping structure is compressed to minimize catheter diameter and maximize flexibility. During electrode positioning and treatment, the shaping structure expands to provide rigidity and maintain stable contact with the renal artery wall.
2Stability of the object's composition
If a catheter uses a rigid structure to maintain uniform electrode contact with the vessel wall, then contact stability improves, but distal tip flexibility and ability to navigate tortuous vasculature deteriorate
Solution Approach 1:
The catheter is divided into distinct segments with different mechanical properties. The proximal portion contains the rigid shaping structure for contact stability, while the distal tip remains flexible for navigation. This segmentation allows each portion to perform its specific function optimally without compromising the other.
Solution Approach 2:
Different portions of the catheter are designed with locally optimized properties. The shaping structure in the proximal portion provides rigidity and structural support for stable electrode contact, while the distal tip maintains flexibility and softness for easy navigation through tortuous vasculature. This local differentiation resolves the contradiction between overall rigidity and distal flexibility.
3Reliability
If continuous circumferential lesions are formed during renal neuromodulation, then treatment efficacy improves, but risk of stenosis formation increases
Solution Approach 1:
The treatment approach segments the circumferential lesions into discrete, non-contiguous segments. Instead of forming a continuous ring of lesions around the vessel, the catheter creates spaced-apart lesions that collectively achieve neuromodulation efficacy while leaving healthy tissue between lesions to maintain vessel patency and reduce stenosis risk.
Solution Approach 2:
The catheter delivers a partial circumferential treatment pattern that provides sufficient neuromodulation effect without completing full 360-degree circumferential lesions. This partial action approach achieves the therapeutic threshold for treating congestive heart failure and renal failure while avoiding the excessive tissue damage that would lead to stenosis.
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 catheter system enables effective renal neuromodulation by forming discrete helical lesions, reducing the risk of acute or late stenosis and improving treatment efficacy for conditions such as congestive heart failure and renal failure.
Implementation Method 1
A shaping structure having a distal end and a proximal end and a length therebetween is provided, the shaping structure being moveable between a delivery state having a first helical shape, and a deployed state having a second helical shape
Implementation Method 2
At least one electrode is carried by the shaping structure
Data Source
AI summary
A catheter apparatus defining a first lumen with a first internal diameter, the catheter apparatus further comprising a shaping structure having a distal end and a proximal end and a length therebetween, the shaping structure being moveable between a delivery state having a first helical shape, and a deployed state having a second helical shape. A deployment member having a second lumen with a second internal diameter, a first portion of the deployment member being positioned within the first lumen and having a third outside diameter sized to enable the deployment member to slide within the first lumen, the deployment member being operably coupled to the distal end of the shaping structure and being configured such that distal axial movement of the deployment member places the shaping structure in the delivery state, and proximal axial movement of the deployment member places the shaping structure in the deployed state.