Rotatable Cryogenic Balloon Ablation Catheter for Lesion Targeting
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Solution Overview
Problem
Accurately positioning treatment devices within the GI tract to target focal lesions such as intestinal metaplasia and dysplasia or 'flat' polyps remains a challenge due to limitations in existing technologies for precise lesion targeting.
Innovation Solution
A cryogenic ablation catheter with an expandable and collapsible balloon and a refrigerant delivery tube assembly, where the refrigerant delivery tube is housed within the catheter shaft for rotary movement, allowing refrigerant to be directed radially outwardly towards the balloon's inner surface for precise cryogenic ablation, combined with a handle assembly for cryogenic gas supply and pressure sensing, facilitating improved lesion targeting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a stationary refrigerant delivery system is used in the balloon catheter, then the device structure is simple, but the ability to accurately target and treat specific lesions is limited
Solution Approach 1:
The refrigerant delivery tube is made rotatable within the catheter shaft, allowing dynamic repositioning of the refrigerant outlet to target different locations on the balloon surface. This rotational capability enables precise lesion targeting while maintaining a relatively simple overall device structure.
Solution Approach 2:
The invention adds rotational freedom to the refrigerant delivery tube, transitioning from a fixed one-dimensional delivery path to a multi-dimensional delivery system. This allows the refrigerant outlet to be oriented in multiple directions, enabling accurate targeting of lesions at different positions on the balloon surface.
2Reliability
If refrigerant is delivered uniformly across the balloon surface, then the delivery system is simple, but the effectiveness of treating specific focal lesions is reduced
Solution Approach 1:
The rotatable refrigerant delivery tube allows concentrated refrigerant delivery to specific localized areas of the balloon surface corresponding to target lesions. This enables differentiated treatment zones where refrigerant can be precisely directed to affected areas while sparing healthy tissue.
Solution Approach 2:
The ability to rotate the refrigerant delivery tube dynamically allows the system to adapt refrigerant delivery to the specific location and orientation of lesions, enhancing treatment effectiveness for focal targets rather than uniform application.
3Adaptability or versatility
If the refrigerant delivery tube is fixed relative to the catheter shaft, then the device is easier to manufacture, but the flexibility to adjust treatment orientation is limited
Solution Approach 1:
The rotatable connection between the refrigerant delivery tube and catheter shaft provides adjustable orientation capability. This allows the tube to be rotated to different angles and positions to match the orientation of lesions, enhancing treatment adaptability while maintaining manufacturability through standardized rotational joints.
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
Enhances the precision and effectiveness of cryogenic ablation by allowing for controlled refrigerant delivery and pressure management, improving the ability to accurately target and treat lesions within the GI tract.
Implementation Method 1
The refrigerant delivery tube is housed within the catheter shaft for rotary movement relative to the catheter shaft
Implementation Method 2
the balloon can press against and cool esophageal target tissue
Implementation Method 3
Ablation assembly also includes a pressure sensing system
Data Source
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AI summary
A cryogenic ablation catheter 12 includes a catheter shaft 16, a balloon 24 and a connector 30 respectively at the catheter shaft proximal and distal ends 18, 20, a refrigerant delivery tube assembly including a refrigerant delivery tube 34 rotatable within the catheter shaft lumen 22, and a refrigerant delivery element 40 with an outlet 42 located inside the balloon which directs refrigerant 44 outwardly against the balloon at different rotary positions as it rotates. A cryogenic balloon ablation system 10 includes the cryogenic ablation catheter, a catheter coupler 119 mating with the connector, a motor 104 including a rotatable hollow motor shaft 102, and a delivery line 100 fluidly coupled to a cryogenic gas source 84 for supplying cryogenic gas to the refrigerant delivery tube. At least one of the refrigerant delivery tube and the delivery line passes at least partway through the hollow motor shaft. The coupling tip 60 of the connector and the refrigerant delivery tube 34 rotate with the motor shaft 102.