Cryoballoon Renal Denervation Device with Feedback Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical devices for denervating renal perivascular nerves often fail to achieve a sustained reduction in blood pressure, leading to limited effectiveness and increased risk of invasive procedures.
Innovation Solution
A medical device with a flexible catheter and cryoballoon that ablates renal perivascular nerves over a large surface area using cryogenic energy, incorporating a pressure sensor for real-time blood pressure monitoring and controlled coolant supply, along with bipolar electrodes for nerve stimulation feedback, to ensure comprehensive denervation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal perivascular nerves are ablated using conventional devices, then some nerve denervation is achieved, but the reduction in blood pressure is insufficient and not sustained
Solution Approach 1:
The cryoballoon is designed to contact the renal artery wall over an extended length (more than 2.5 cm, preferably at least 3 cm) in the longitudinal dimension, and ablate nerves over a comparable length simultaneously. This extends the ablation from a point or small area to a distributed three-dimensional zone along the artery, achieving comprehensive denervation of all renal perivascular nerves while maintaining safe tissue temperatures through the large surface area.
2Reliability
If a large surface area is used for ablation, then comprehensive nerve denervation is achieved, but the risk of vascular complications increases
Solution Approach 1:
The device utilizes cryogenic temperatures (between -30 and -80 °C) instead of conventional thermal ablation temperatures. This parameter change in temperature allows for effective nerve denervation while being more selective for neural tissue and less damaging to surrounding vascular structures. The cryoballoon maintains these low temperatures over a large surface area without causing the vascular complications associated with high-temperature ablation over similar areas.
3Temperature
If continuous coolant supply is used, then sustained low temperature is maintained for effective ablation, but tissue damage and vascular complications increase
Solution Approach 1:
The device incorporates a pressure sensor on the catheter to monitor blood pressure in real-time during the ablation procedure. The control system uses this feedback to dynamically adjust the coolant supply to the cryoballoon. When blood pressure changes indicate potential tissue damage or vascular complications, the system automatically modifies coolant flow to prevent harm, while maintaining sufficiently low temperatures for effective nerve denervation.
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 device achieves a sustained reduction in blood pressure by ablating nerves over the entire length and circumference of the renal artery, minimizing tissue damage and reducing risks of vascular complications, such as narrowing and perforation.
Implementation Method 1
Evaporation of the coolant in the balloon creates a temperature on the surface of the balloon, preferably between -30 and -80 °C, which is used to ablate the renal perivascular nerves
Implementation Method 2
Evaporation of the coolant in the balloon creates a temperature on the surface of the balloon
Implementation Method 3
At least one bipolar electrode is arranged on the surface of the balloon and connected to a power source for delivering an electrical pulse or a sequence of pulses or a frequency for stimulating the perivascular nerves
Implementation Method 4
Document US 2014/249520 A1 also discloses a device for denervating renal nerves using a cryoballoon comprising a pressure sensor on the outside of the cryoballoon
Data Source
Figure 1
Figure 2
Figure 3~4
AI summary
The present invention relates to a medical device (1) for denervation of the renal perivascular nerves, comprising a catheter (2) with a flexible shaft for insertion into the renal artery of a patient. The shaft has an inner lumen (5) for supplying a cryogenic agent and a cryoballoon (3) arranged at the distal end of the shaft. At least one bipolar electrode (16) for delivering an electrical impulse to stimulate the perivascular nerves is arranged on the cryoballoon (3). To ensure ablation of the renal perivascular nerves along their entire length, the cryoballoon (3) is designed to contact the wall of the renal artery for a length of more than 2.5 cm in the direction of blood flow and to ablate continuously and simultaneously over a length of at least 2.5 cm.