Deployable Cryo-Ablation Injection Tube
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Solution Overview
Problem
Current medical devices for thermal ablation procedures, such as those for treating cardiac tissue, face inefficiencies due to fixed geometries that don't adapt to varying patient anatomy and poor heat transfer efficiency, leading to inaccuracies, prolonged procedures, and increased risks.
Innovation Solution
A medical device with a fluid injection tube that can change configuration from linear to radial or helical, using a shape memory material and a deformable membrane, allowing for adjustable geometry and enhanced heat transfer efficiency by deploying a coolant through apertures to target specific tissue areas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If multiple catheters with fixed geometries are used to create continuous lesions, then the desired ablation pattern can be achieved, but the procedure time increases and placement accuracy decreases due to sequential removal and replacement
Solution Approach 1:
The catheter employs a deployable injection tube that can transition from a compressed delivery configuration to an expanded operational configuration. This dynamic transformation allows a single catheter to provide multiple geometries and dimensions, eliminating the need for sequential catheter exchanges while maintaining placement accuracy and reducing procedure time.
Solution Approach 2:
The injection tube is designed to provide a range of varying dimensions and configurations within a single device, allowing it to perform multiple functions that previously required several different catheters. This multi-functionality enables continuous lesion creation without removing and replacing devices, thereby improving placement accuracy and reducing procedure time.
2Adaptability or versatility
If multiple devices are exchanged during the procedure, then various fixed dimensions can be utilized, but the risks of complications from repeatedly inserting and retracting devices increase
Solution Approach 1:
The injection tube transitions from a compressed state during delivery to an expanded state during operation, providing dimensional variety without requiring device exchange. This dynamic capability maintains patient safety by eliminating repeated insertions and retractions while still offering the necessary adaptability for different anatomical configurations.
Solution Approach 2:
The injection tube is nested within the catheter body in a compressed configuration during delivery, then deployed outward to provide the required dimensional variety. This nesting approach allows multiple configurations to be contained within a single safe delivery system, improving patient safety while maintaining adaptability.
3Device complexity
If a fixed geometry device is used, then the device structure is simple, but it is limited to use only where the fixed dimensions are appropriate
Solution Approach 1:
The injection tube can dynamically change its geometry and dimensions by deploying from a compressed to an expanded configuration. This dynamic capability provides anatomical compatibility for various patient-specific geometries while maintaining relatively simple device structure through the use of shape memory materials and elastic membranes.
Solution Approach 2:
The injection tube changes its physical parameters (geometry, dimensions, configuration) by transitioning between compressed and expanded states. This parameter change capability allows the device to adapt to different anatomical structures without significantly complicating the overall device structure, as the changes are achieved through material properties rather than complex mechanical systems.
4Power
If thermal energy is transferred to treat tissue, then ablation can be achieved, but heat transfer to non-target tissues such as blood or body fluids reduces treatment efficacy
Solution Approach 1:
The injection tube can be configured to conform to the specific geometry of the target tissue, concentrating thermal energy delivery precisely where needed. This local adaptation minimizes heat transfer to non-target tissues such as blood or body fluids, improving treatment efficacy while reducing unnecessary thermal load.
Solution Approach 2:
The deployable injection tube allows dynamic adjustment of the thermal contact interface to match the target tissue geometry. This dynamic configuration optimizes heat transfer to the intended target while minimizing thermal energy loss to surrounding non-target tissues, thereby improving treatment efficacy and reducing thermal load.
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
Enables precise, continuous ablative patterns with reduced thermal load on non-target tissues, improving procedure efficiency and safety by allowing a single device to accommodate varied anatomical shapes and increasing heat transfer efficiency.
Implementation Method 1
using a shape memory material and a deformable membrane
Implementation Method 2
deploying a coolant through apertures to target specific tissue areas
Implementation Method 3
A cryogenic coolant source may be in fluid communication with the fluid injection tube
Implementation Method 4
cryogenic cooling
Data Source
AI summary
A medical system is provided, including a catheter body having a proximal portion and a distal portion; a shaft slidably disposed within a portion of the catheter body, the shaft defining a distal tip; a fluid injection tube coupled to the distal portion of the catheter body and the distal tip of the shaft, the fluid injection tube being transitionable from a first geometric configuration to a second geometric configuration; a membrane coupled to the shaft and enclosing at least a portion of the fluid injection tube therein; and a coolant source in fluid communication with the fluid injection tube. The first geometric configuration may be substantially linear, the second geometric configuration may be substantially helical, and the membrane may be tensioned across at least a portion of the fluid injection tube in the second geometric configuration.