Percutaneous Heart Valve Delivery System with Steerable Sheath
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Solution Overview
Problem
Current treatments for mitral and tricuspid regurgitation often require invasive open heart surgery, which is risky and complex, making minimally invasive percutaneous procedures necessary for safer and more efficient treatment, especially for high-risk patients.
Innovation Solution
A delivery system for percutaneous heart valve repair, comprising a steerable sheath, steering mechanism, ball joint mechanism, main knob assembly, stabilizing tool, and actuation mechanism, designed to provide percutaneous access, manipulate, and securely deploy an implant within the heart while ensuring intimate contact and safe retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used to treat mitral and tricuspid regurgitation, then effective treatment can be achieved, but the procedure becomes highly invasive with high risk and complexity
Solution Approach 1:
A delivery system acts as an intermediary device that transports the implant from outside the body to the target site within the heart through percutaneous access. The delivery system includes a catheter, steering mechanism, and release mechanism that enable minimally invasive deployment of the implant without requiring open heart surgery, thus reducing surgical invasiveness while maintaining treatment effectiveness
Solution Approach 2:
The treatment approach is segmented into separate functional components: the delivery system (catheter, steering mechanism, release mechanism) and the implant (mitral valve repair device or tricuspid valve repair device). This segmentation allows the implant to be delivered and deployed independently through minimally invasive percutaneous access, avoiding the need for complex open heart surgery while maintaining treatment effectiveness
2Object-affected harmful factors
If percutaneous procedures are used to treat mitral and tricuspid regurgitation, then surgical risk is reduced, but the complexity of the procedure increases
Solution Approach 1:
The delivery system serves as an intermediary that simplifies the percutaneous procedure by integrating multiple functions into a single device: navigation through the catheter, positioning via steering mechanism, and deployment through the release mechanism. This integration reduces procedure complexity despite the minimally invasive approach, while simultaneously reducing surgical risk compared to open heart surgery
Solution Approach 2:
The delivery system incorporates feedback mechanisms including the steering mechanism that allows real-time adjustment of catheter position and orientation, and the release mechanism that provides controlled deployment of the implant. These feedback-controlled features enable precise implant placement through percutaneous access, reducing both surgical risk and procedure complexity by providing operator control and verification during the minimally invasive procedure
Data Source
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AI summary
Disclosed herein is a delivery system for percutaneous heart valve repair, the delivery system including a steerable sheath configured to provide percutaneous access into a heart and to deliver an implant. The system may also have a steering mechanism configured to manipulate and orient the implant, a ball joint mechanism configured to connect the steerable sheath to the steering mechanism, a main knob assembly configured to advance and retract a multilumen shaft assembly, a stabilizing tool including a plurality of prongs configured to engage the implant within the heart to make an intimate contact with the heart tissue using a stabilizer and a tongue assembly, and a back assembly including: the actuation mechanism, a suture routing mechanism, a tip lock mechanism, and a back cover configured to protect all sutures being cut by mistake.