Focal Ablation Balloon with Thermally Conductive Region
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Solution Overview
Problem
Current cryoablation technologies for removing focal lesions in the GI tract lack control over energy dosage, leading to complications such as bleeding and inadequate tissue ablation, particularly with existing methods like Endoscopic Mucosal Resection, Argon Plasma Coagulation, and Radio Frequency Ablation.
Innovation Solution
A focal ablation assembly comprising a cryogenic catheter, a balloon, and a reinforcing element within an endoscope, where the balloon has a thermally conductive therapeutic region with no thermal insulation, allowing precise control over refrigerant delivery and evaporation temperature to achieve targeted tissue ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If existing cryoablation technologies spray cryogen directly onto the body lumen, then tissue ablation is achieved, but control of energy dosage is inadequate
Solution Approach 1:
The patent introduces a balloon as an intermediary medium between the cryogen delivery system and the target tissue. The balloon is inflated with cryogen to create a controlled thermal interface, allowing precise energy dosage delivery while maintaining reliable tissue ablation. This mediator enables better control compared to direct spray methods.
Solution Approach 2:
The patent utilizes phase change of the cryogen (from liquid to gas) within the balloon to control energy delivery. By controlling the phase transition parameters and the balloon inflation state, precise control over the thermal energy dosage is achieved while ensuring effective tissue ablation.
2Manufacturing precision
If a balloon is used for cryoablation, then tissue contact is improved, but thermal insulation may reduce treatment precision
Solution Approach 1:
The balloon is designed with non-uniform thermal properties, with the region contacting the target tissue having enhanced thermal conductivity. This local quality optimization ensures precise energy delivery at the treatment site while allowing the rest of the balloon structure to provide necessary mechanical support and insulation where needed.
Solution Approach 2:
The balloon employs composite material construction with regions of different thermal conductivities. The tissue-contacting portion uses materials with higher thermal conductivity for precise energy transfer, while other portions use insulating materials to minimize unnecessary heat loss and maintain structural integrity.
3Measurement precision
If refrigerant is delivered directly to tissue, then ablation is achieved, but control over evaporation temperature and mass flow rate is limited
Solution Approach 1:
The balloon serves as a controlled intermediary chamber that regulates refrigerant delivery. By inflating the balloon with controlled amounts of refrigerant, precise control over evaporation temperature and mass flow rate is achieved. The balloon's expansion and contraction provide a simple yet effective mechanism for controlling refrigerant release without complex delivery systems.
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
This solution enables controlled and repeatable cryoablation by managing evaporation temperature and mass flow rate, reducing complications and improving the precision of tissue ablation, thereby enhancing the safety and effectiveness of the procedure.
Implementation Method 1
The balloon comprises a flexible, tissue-conformable, thermally conductive therapeutic region, the thermally conductive therapeutic region providing effectively no thermal insulation
Implementation Method 2
managed evaporation temperature and mass flow rate
Implementation Method 3
managed evaporation temperature and mass flow rate
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
One focal ablation assembly (72), used with an endoscope (12) comprising an endoscopic tube (16), comprises a cryogenic catheter (26), a balloon (74) and a reinforcing element (88). The cryogenic catheter is placeable within the endoscopic tube channel (28) and has a distal end (34) placeable at the distal end (24) of the endoscopic tube. The balloon is mountable to the catheter distal end (34) and extends distally of both of the distal ends. The reinforcing element at least partially defines the shape of the balloon in the expanded state. The balloon has a thermally conductive therapeutic region (36) which provides effectively no thermal insulation. Another focal ablation assembly (14) uses a cap (22) instead of the balloon. The cap substantially maintains its shape during use while not causing tissue trauma.