Pericardial Transection Device with Suction Stabilization
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Solution Overview
Problem
There is currently no therapeutic option for patients with heart failure with preserved ejection fraction (HFpEF) that specifically targets pericardial restraint, which exacerbates heart failure symptoms by restricting heart filling and causing breathing difficulties during physical activity.
Innovation Solution
A medical device comprising a multi-lumen catheter with an incision device and suction devices is used to create elongated incisions within the pericardium, reducing pericardial restraint and alleviating heart failure symptoms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cutting device is used to create incisions in the pericardium, then pericardial restraint is reduced and heart function is improved, but the risk of uncontrolled cutting and damage to surrounding tissue increases
Solution Approach 1:
The patent introduces an intermediary mechanism (suction device with engagement elements) between the cutting surface and the pericardial tissue. This intermediary captures and controls the tissue before cutting occurs, preventing uncontrolled movement and reducing the risk of damage to surrounding structures. The suction device acts as a mediator that stabilizes the interaction between the cutting element and the delicate pericardial tissue.
Solution Approach 2:
The patent applies preliminary action by engaging the pericardial tissue with suction devices before the cutting surface makes contact. The engagement elements (suction cups, grippers, or clamps) secure the tissue in advance, ensuring it remains stable and controlled during the subsequent cutting process. This preliminary stabilization prevents tissue displacement and reduces the risk of harmful effects during incision creation.
2Productivity
If the cutting surface is always exposed, then cutting efficiency is improved, but the risk of accidental activation and uncontrolled cutting increases
Solution Approach 1:
The patent employs nesting by placing the cutting surface within a protective housing or sheath that can be retracted or deployed as needed. When not in use, the cutting surface is nested within the housing, preventing accidental activation. When cutting is required, the housing is retracted to expose the cutting surface, allowing efficient cutting while maintaining safety during transport and non-use periods.
Solution Approach 2:
The patent applies dynamics by making the cutting surface movable between exposed and retracted states rather than permanently fixed in one position. The cutting surface can be dynamically deployed when needed for cutting and retracted when not in use, allowing the system to adapt its state based on operational requirements. This dynamic configuration balances cutting efficiency with safety by controlling exposure timing.
3Stability of the object's composition
If multiple suction devices are used to engage pericardial tissue, then tissue engagement stability is improved, but device complexity increases
Solution Approach 1:
The patent applies segmentation by dividing the tissue engagement function into multiple discrete suction devices distributed along the incision channel. Each suction device independently engages a portion of the pericardial tissue, providing stable and distributed contact. This segmented approach enhances overall stability while allowing each individual component to remain relatively simple in design.
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 effectively reduces pericardial restraint, improving heart function and alleviating symptoms such as exertional dyspnea in patients with HFpEF, thereby addressing the unmet therapeutic need for this patient population.
Implementation Method 1
one or more suction devices adjacent to the incision channel. The one or more suction devices are structured to engage a pericardial tissue
Data Source
AI summary
A medical device is provided. The medical device includes a multi-lumen catheter. The device also includes an incision device operably coupled to the distal end of the multi-lumen catheter. The incision device includes an incision channel defined along the incision device. The device further includes one or more suction devices adjacent to the incision channel. The device still further includes a cutting surface disposed within the incision channel. The cutting surface is structured to move between a retracted position and a deployed position. In an instance in which the cutting surface is in the retracted position, the cutting surface is disposed within the incision channel. In an instance in which the cutting surface is in the deployed position, the cutting surface at least partially protrudes from the incision channel.