Retractable Cutting Apparatus for Pericardial Transection
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Solution Overview
Problem
Current therapeutic options do not effectively address pericardial restraint, a condition that exacerbates heart failure with preserved ejection fraction (HFpEF), leading to exertional dyspnea and significant breathing difficulties.
Innovation Solution
A medical device comprising a catheter with a retractable cutting apparatus, which creates elongated incisions within the pericardium to reduce pericardial restraint. The device includes a catheter with at least one lumen, a longitudinal axis, a proximal end, and a distal end, coupled with an incision device having an incision channel and a retractable cutting apparatus that moves between a retracted and deployed position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cutting device is deployed within the pericardium to create incisions, then pericardial restraint is reduced and breathing difficulties are alleviated, but the risk of uncontrolled cutting and damage to surrounding tissue increases
Solution Approach 1:
The cutting apparatus is nested within a protective sheath that confines the blade during navigation. The blade can be extended or retracted within the sheath, allowing controlled deployment only when needed. This nesting structure prevents accidental contact with surrounding tissue while maintaining the ability to make precise incisions in the pericardium.
Solution Approach 2:
The cutting apparatus features dynamic controllability where the blade can be extended, retracted, and positioned at different depths within the pericardium. The operator can control the blade's deployment timing and extent, allowing adaptive adjustment based on real-time anatomical conditions and reducing risk of uncontrolled cutting.
2Object-affected harmful factors
If the cutting apparatus is made retractable to improve safety, then the device complexity increases due to additional mechanisms required for extension and retraction
Solution Approach 1:
The retractable blade is nested within the sheath structure, utilizing the existing catheter framework. The retraction mechanism leverages the sheath's natural containment capability, avoiding the need for separate complex retraction systems. This integrated nesting approach adds minimal complexity while achieving the safety benefits of retraction.
Solution Approach 2:
Instead of having a permanently exposed blade that requires complex shielding mechanisms, the design inverts the approach by having a permanently retracted blade within the sheath that only extends when needed. This inversion simplifies the overall mechanism by making the retracted state the default and only requiring extension capability rather than continuous protection.
3Object-affected harmful factors
If the blade is kept retracted during navigation to prevent tissue damage, then the time required for deployment and incision creation increases
Solution Approach 1:
The sheath is pre-positioned within the pericardium during navigation, with the blade already contained and protected. The preliminary placement of the sheath establishes the correct positioning before blade deployment is needed, eliminating the need for time-consuming adjustments after blade extension. The blade can then be quickly deployed from the pre-positioned sheath.
Solution Approach 2:
The blade transition from retracted to extended state is designed to be rapid and smooth, minimizing deployment time. The dynamic mechanism allows quick extension when needed while maintaining the protected retracted state during navigation, reducing the time penalty associated with safe blade management.
Data Source
AI summary
A medical device includes an incision device operably coupled to a distal end of an elongate catheter. The incision device includes an incision channel, and a retractable cutting apparatus disposed within the incision channel. The retractable cutting apparatus includes a first cutting apparatus link that is rotatably fixed proximate to a distal end of the incision channel and a second cutting apparatus link that is attached to the first link proximal end of the first cutting apparatus link. The first cutting apparatus preferably includes a first cutting surface proximate to the first link proximal end of the first cutting apparatus link and the second cutting apparatus link includes a second cutting surface. The retractable cutting apparatus also includes a guide member coupled to cause the retractable cutting apparatus to move between a retracted position and a deployed position.