Cryoadhesive Transseptal Puncture Device
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Solution Overview
Problem
Current methods for accessing the left atrium of the heart, such as transseptal puncture, often result in life-threatening complications due to unintentional puncturing of atrial walls, caused by the beating heart, slippery myocardium, and septal irregularities, leading to invasive and traumatic procedures.
Innovation Solution
A tissue puncturing device with a cryoadhesive segment and a thermally-transmissive region, cooled by a cryogenic coolant source, is used to effectively and safely engage and puncture tissue by cryoadhering to the septum, allowing precise puncture without causing injury, using a Peltier device and sensors to maintain a temperature between 0° C. and −30° C.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical clamps or suction devices are used to anchor tissue, then tissue stabilization is achieved, but the procedure becomes significantly invasive requiring insertion through the rib cage and causes excess force or trauma to the engaged tissue
Solution Approach 1:
The patent replaces mechanical clamps and suction devices with a cryoadhesive segment that uses cryogenic cooling to freeze and adhere to the tissue. This substitution eliminates the need for invasive mechanical anchoring while providing stable tissue engagement through controlled freezing, thereby reducing tissue trauma and invasiveness.
Solution Approach 2:
The invention changes the physical state of the tissue by applying cryogenic temperatures (freezing) to create adhesion. By controlling the temperature parameter of the cryoadhesive segment, the device achieves reliable tissue stabilization without the excessive force and trauma associated with mechanical clamping or suction methods.
2Ease of operation
If transseptal puncture is performed to access the left atrium, then access to the left side of the heart is achieved, but life-threatening complications such as pericardial tamponade, aortic perforation, and systemic embolization may occur
Solution Approach 1:
The cryoadhesive segment is applied to the septum before puncture to freeze and stabilize the tissue. This preliminary freezing action anchors the puncturing device firmly to the septum, enabling precise control during puncture and reducing the risk of unintentional puncturing of atrial walls that leads to complications.
Solution Approach 2:
The cryoadhesive segment acts as an intermediary between the puncturing device and the tissue. By freezing the tissue, it creates a stable interface that allows for controlled puncture while minimizing the risk of complications such as pericardial tamponade and aortic perforation.
3Stability of the object's composition
If the heart is beating and the myocardium is slippery, then natural physiological conditions are maintained, but accurate puncture of the septum becomes difficult due to tissue movement and device steering challenges
Solution Approach 1:
The cryoadhesive segment freezes the septal tissue before puncture, stabilizing it in place. This preliminary freezing counteracts the effects of heart beating and slippery myocardium, enabling accurate puncture while maintaining physiological conditions in the rest of the heart.
Solution Approach 2:
By changing the temperature parameter of the targeted tissue through cryoadhesion, the device stabilizes the moving septum without affecting the overall physiological state of the heart. This localized parameter change enables precise puncture accuracy despite continuous heart activity.
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 enables minimally invasive tissue engagement and puncture, reducing the risk of complications by providing stable anchoring and precise control, preventing unwanted trauma and injury to the heart tissue.
Implementation Method 1
A tissue puncturing device with a cryoadhesive segment and a thermally-transmissive region, cooled by a cryogenic coolant source
Implementation Method 2
a cryoadhesive segment coupled to the distal portion of the elongate body and in thermal communication with the fluid flow path
Implementation Method 3
using a Peltier device and sensors to maintain a temperature between 0° C. and −30° C.
Data Source
AI summary
A cryogenic medical system and method of use thereof for transseptal puncturing is disclosed, including a medical device having an elongate body with a fluid flow path therein, a thermally-transmissive region coupled to the elongate body in thermal communication with the fluid flow path, and a puncturing element movably coupled to the elongate body; and a cryogenic coolant source in fluid communication with the fluid flow path. The medical device may alternatively include an elongate body, a thermally-transmissive region coupled to the elongate body, a thermo-electric cooler in thermal communication with the thermally-transmissive region, and a puncturing element movably coupled to the elongate body.