Expandable Balloon Catheter for Renal Neuromodulation
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Solution Overview
Problem
Current renal neuromodulation techniques face challenges in achieving precise and accurate positioning of needles within renal vessels to deliver chemical agents effectively, due to the tortuous anatomy and variability of renal arteries, which can lead to inefficiencies and inaccuracies in treating conditions related to excessive sympathetic nervous system activation.
Innovation Solution
The development of a catheter system equipped with an elongated member, a needle, and an expandable balloon with a needle guide, which navigates through the vasculature to a target site, allowing the needle to puncture the vessel wall accurately and the balloon to stabilize and center the needle, ensuring precise delivery of chemical agents to renal nerves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional catheter-based needle delivery is used without an expandable balloon guide, then the device structure is simpler, but the positioning precision and accuracy of the needle at the target treatment site deteriorates
Solution Approach 1:
An expandable balloon with integrated needle guides is introduced as an intermediary component between the catheter and the needle. The balloon provides a stable platform with pre-formed channels that guide the needle to the precise target location on the vessel wall, eliminating the need for complex external guidance systems while maintaining simple catheter structure.
Solution Approach 2:
The needle guides are pre-formed within the expandable balloon structure before deployment. When the balloon is inflated, these pre-formed channels automatically position the needle at the correct depth and angle relative to the vessel wall, eliminating the need for real-time adjustment or complex positioning mechanisms during the procedure.
2Manufacturing precision
If manual needle positioning without a balloon guide is used, then the device operation is simpler, but the circumferential and axial positioning accuracy of the needle deteriorates
Solution Approach 1:
The expandable balloon acts as a mediator that translates simple catheter insertion into precise needle placement. The balloon's pre-formed needle guides provide inherent positioning capabilities, allowing operators to achieve accurate circumferential and axial needle placement without requiring complex manual positioning skills or additional guidance equipment.
3Reliability
If the needle is delivered without an expandable balloon stabilization mechanism, then the delivery mechanism is simpler, but the consistency and repeatability of needle penetration depth deteriorates
Solution Approach 1:
The expandable balloon serves as a stabilizing intermediary that ensures consistent needle penetration depth. The balloon's rigidified structure upon inflation provides a stable reference frame, and the pre-formed needle guides ensure that each needle insertion reaches the same depth and angle, dramatically improving repeatability without requiring complex feedback or adjustment mechanisms.
Data Source
AI summary
An example catheter includes an elongated member configured to be navigated through vasculature of a patient to a target treatment site in a vessel of the patient, a needle positioned at a distal portion of the elongated member, the needle configured to be within the elongated member when in a delivery configuration and radially extended to puncture a vessel wall of the vessel at the target treatment site when in a deployed configuration, and an expandable balloon including a needle guide configured to position a distal end of the needle at a predetermined distance from a central axis of the elongated member when the balloon is in an expanded configuration and the needle is in the deployed configuration.